Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Mycoses

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Dermatologic Agents

All Drugs and Chemicals

Antineoplastic Agents

Petrolatum

Mechlorethamine

Nitrogen Mustard Compounds

Alkylating Agents

Antineoplastic Agents, Alkylating

PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF

AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF

All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment

mechlorethamine-MCH (nitrogen mustard)

Stuart Lessin, M.D.

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).

The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.

Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)

The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment

Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.

Yaupon Therapeutics

There were a total of 130 participants randomized to each treatment arm. However, 2 from the PG group and 3 from the AP group did not receive drug and are not included in the safety population.

Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel

PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel

Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%

AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

H. Jeffrey Wilkins, MD

PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel

Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%

AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%

Ratio of Response Rates Based on CAILS

Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks

Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%

Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)

Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel

PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel

Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%

AP- Mechlorethamine 0.02% Compounded in Aquaphor

Overall Study

Lymphoma, Follicular

Lymphoma, Large-Cell, Anaplastic

Lymphomatoid Papulosis

Follicular Lymphoma

Anti-Inflammatory Agents

Anti-Infective Agents

Central Nervous System Depressants

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Ethanol

Bexarotene

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas)

The second plaque will be treated using a needle-free injector system.

After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

The first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).

The second plaque will be treated using a needle-free injector system.

After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

The Med-Jet injector is a needle-free injection system that consists of a hand-held firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, and disposable splash guard. The Med-Jet injector is designed to deliver drugs or biologics into the intradermal, subcutaneous, or intramuscular tissues, by means of a narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers the fluid to the target tissue

Med-Jet Injector

The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.20 ml of injected fluid).

Bexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration.

Bexarotene 1% Top Gel

Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.

Nitrogen Mustard

A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.

Conventional syringe

Amy Johnson, MD

Kevin Cooper, MD

A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.

Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).

The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.

Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.

Number of participants that prefer traditional treatment versus MedJet.

Tolerability will be measured using Pruritus score assessment in the Medjet and topical therapy cohorts using a visual standard analog itching scale 0 (no itch) to 10 (worst itch imaginable) with the affected plaques at each indicated visit.

The quality of life assessment will be done using the Dermatology Life Quality Index survey (DLQI) which will include a series of topics related to the skin condition including symptoms, feelings, effects on daily life, employment or schooling, personal relationships, and treatment.

Each of the ten (10) questions are scored from 0 to 3, giving a score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Resulting scores are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.

Composite Assessment of Index Lesion Severity (CAILS) is an assessment of individual lesions by the investigator of disease severity at the time of evaluation which can be used to monitor and compare lesions over time. CAILS is a 5-criterion scale ranging from 0 (no evidence) to 8 (severe), incorporating an assessment of the size of the lesion and severity of erythema, scaling, plaque elevation, and hypo- or hyperpigmentation. When making the assessment of severity, the Investigator will score the area with most clearance (ie, have scores of 0) within the treated plaque.

Case Comprehensive Cancer Center

Hodgkin Disease

Hodgkin Lymphoma

Antirheumatic Agents

Etoposide

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Lenograstim

Etoposide phosphate

Bleomycin

Vinblastine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Adriamycin®

Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.

Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.

May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).

G-CSF

Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.

Radiotherapy

Jamie Flerlage, MD

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone\* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

\* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Patient QOL will be measured at multiple time points to assess the patient's functioning.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.

Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.

Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score.

Relationship between quality of life and symptom distress instruments aggregated across multiple time points \[At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Relationship between quality of life and symptom distress across multiple time points \[completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy\]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.

Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50.

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage \<III showed a better outcome but was not statistically significant.

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized.

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome.

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results.

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings.

St. Jude Children's Research Hospital

Intermediate risk single arm study defined as

* EITHER Ann Arbor stage IB and IIIA,
* OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Stanford V Chemotherapy

Participants receive 12 weeks of Stanford V chemotherapy:

Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Age, Continuous

Dana Farber Cancer Institute, Boston, MA

Main Medical Center, Portland, ME

Massachusetts General Hospital, Boston, MA

Rady Children's Hospital, San Diego, CA

St. Jude Children's Research Hospital, Memphis, TN

Stanford University Medical Center, Palo Alto, CA

Participating Site Location

The association of age with EFS was compared. P values from Score test were computed for the statistical significance.

3-year Event-Free Survival Probability

Disease Failure Rate Within Radiation Fields

Cumulative incidence of distant failure at 3 years

Cumulative incidence of local failure at 3 years

Local and Distant Failure for Children Treated With Tailored-field Radiation

Prognostic Factors for Treatment Failure: Age

Evaluation completed prior to the start of treatment.

Pre-therapy

Evaluation completed following 2 courses of therapy, approximately week 8 after start.

Week 8

Evaluation completed following 4 courses of therapy, approximately week 16 after start.

Week 12

Evaluation completed following radiation therapy.

After Radiation

Evaluation completed approximately 3-6 months following completion of therapy.

Off-therapy

Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides	NCT00168064	Mycosis Fungoid...	mechlorethamine...	-	Yaupon Therapeutics
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.	NCT05106192	Mycosis Fungoid... Cutaneous T-cel... Non Hodgkin Lym... Lymphomatoid Pa... Lymphoma, Large... Lymphoma, Folli...	Med-Jet Injecto... Triamcinolone A... Bexarotene 1% T... Nitrogen Mustar... Conventional sy...	18 Years -	Case Comprehensive Cancer Center
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma	NCT00352027	Hodgkin's Lymph...	Adriamycin® Vinblastine Nitrogen Mustar... Cyclophosphamid... Vincristine Bleomycin Etoposide Prednisone G-CSF Radiotherapy	- 21 Years	St. Jude Children's Research Hospital
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.	NCT05106192	Mycosis Fungoid... Cutaneous T-cel... Non Hodgkin Lym... Lymphomatoid Pa... Lymphoma, Large... Lymphoma, Folli...	Med-Jet Injecto... Triamcinolone A... Bexarotene 1% T... Nitrogen Mustar... Conventional sy...	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for nitrogen mustard