Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Rare Diseases

Uterine Cervical Neoplasms

Syndrome

Recurrence

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Pleural Effusion

Prostatic Neoplasms

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Stomach Neoplasms

Carcinoma, Renal Cell

Neoplasm Metastasis

Adenocarcinoma, Follicular

Lung Neoplasms

Pleural Effusion, Malignant

Urinary Bladder Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Liver Neoplasms

Breast Neoplasms, Male

Testicular Neoplasms

Thyroid Carcinoma, Anaplastic

Anus Neoplasms

Adrenocortical Carcinoma

Carcinoma, Adenoid Cystic

Carcinoid Tumor

Carcinoma, Medullary

Pericardial Effusion

Inflammatory Breast Neoplasms

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Glucagonoma

Zollinger-Ellison Syndrome

Somatostatinoma

Esophageal Cancer

Pancreatic Cancer

Papillary Thyroid Carcinoma

Bile Duct Cancer

Renal Cell Carcinoma

Thyroid Cancer, Follicular

Stomach Cancer

Vaginal Cancer

Primary Liver Cancer

Gallbladder Cancer

Breast Cancer, Male

Germ Cells Tumors

Anaplastic Thyroid Cancer

Anal Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Vulvar Cancer

Small Intestinal Adenocarcinoma

Adenoid Cystic Carcinoma

Thyroid Cancer, Medullary

Testicular Germ Cell Tumor

Inflammatory Breast Cancer

Small Intestine Cancer

Urethral Cancer

Parathyroid Carcinoma

Mucoepidermoid Carcinoma

WDHA Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Trastuzumab

Liver Extracts

Parathyroid Hormone

Tipifarnib

Pancreatic Polypeptide

Antineoplastic Agents, Immunological

Cola

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

trastuzumab

tipifarnib

Anthony W. Tolcher, MD

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.

II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.

III. Determine the antitumor activity of this treatment regimen in these patients.

IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study of R115777.

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

Patients are followed every 30 days until toxicity resolves.

Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer

National Cancer Institute (NCI)

Neoplasms, Second Primary

Skin Neoplasms

Neoplastic Processes

Skin Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days

One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment

Rose Marie Cavanna-Mast

Julie E Lang, MD

This study evaluates a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of cutaneous metastases from non-melanoma cancer in adults. Three concentrations of SOR007 will be evaluated in dose-rising cohorts of three. An expanded cohort will treat additional subjects at the maximum tolerated dose.

This is a Phase 1/2, open-label, dose-rising study evaluating the safety, tolerability and preliminary efficacy of three concentrations of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment (0.15%, 1.0%, and 2.0%) applied to non-melanoma cutaneous metastases. A treatment area of 50 cm2 will be selected by the Investigator. Using a gloved hand, subjects will apply one Finger Tip Unit (FTU) of SOR007 to the 50 cm2 treatment area twice daily at approximately the same time each day for 28 days, with the option of extending treatment an additional 28 days to total 56 days for subjects in the dose expansion phase. At each visit (Days 1, 8, 15, 29, and 43 for 28 treatment days; Days 8, 15, 29, 57, and 70 for 56 treatment days), at least two global and two close-up color photographs of the treatment area will be taken (with a ruler for scale). The photographs will be analyzed with ImageJ. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter). The study will include a dose escalation phase and a dose expansion phase.

In the dose escalation phase, formal safety reviews will be conducted after the last subject in each cohort of three subjects completes 15 days of treatment. The next dose level will enroll upon a finding of safety and tolerability. The top dose or the maximum tolerated dose (if DLT occurs) will be taken into the dose expansion phase and additional subjects will be enrolled to reach a maximum of 16 subjects at that dose.

Phase 1/2, open-label, dose-rising trial of three concentrations of SOR007 (0.15%, 1.0%, 2.0%).

During the dose escalation phase, the study will follow a standard 3+3 dose-ascending design. If a single dose limiting toxicity (DLT) is identified in one of three subjects in the cohort, a further three subjects will be enrolled at the same dose level. If one or more DLT occur in the three additional subjects enrolled in the cohort, dose escalation will stop and the prior dose level will be regarded as the Maximum Tolerated Dose (MTD) and taken forward into the dose expansion phase. If no further DLT are identified, dose escalation will continue, until either a DLT is identified at a higher dose or the top dose of 2% is reached.

In the dose expansion phase, additional subjects will be enrolled up to a maximum of 12 subjects at the dose determined to be the MTD (or the top dose, 2.0% SOR007).

Study of Topical SOR007 Ointment for Cutaneous Metastases

Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases

Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Objective Clinical Response (Complete Clinical Response (CR) + Partial Response (PR)) is defined as the percentage of study subjects who achieve complete clinical response or partial response 14 days after last treatment (Day 43 or Day 70).

Complete clinical response (CR) is defined as absence of any detectable residual disease in the treatment area; partial response (PR) as at least a 30% decrease in the sum of the diameters of eligible lesion(s) within the treatment area compared to baseline; progressive disease (PD) as at least a 20% increase in the sum of diameters of eligible lesion(s) within the treatment area, taking as reference the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); and stable disease (SD) as between that defined as PR or PD. Eligible lesions will be determined at baseline by the RECIST definition of measurable tumors (≥ 10mm in its longest diameter).

Change in pain at the treatment area will be measured by the Numeric Rating Scale (NRS-11). The numerical scale ranges from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." A lower score equates to less severe pain (better outcome) and a higher score equates to more severe pain (worse outcome).

Objective Tumor Response (OTR), defined as the difference in the lesion size within the treatment area between baseline and 14 days after the last dose in the dose group i.e. Day 43 for dose escalation Subjects, and dose expansion Group A Subjects; Day 70 for dose expansion Group B Subjects; or between baseline and last tumor assessment for early terminators. Four OTRs are calculated based on different definitions of "lesion size": 1) Area of the primary eligible lesion, 2) Sum of area of all eligible lesions, 3) Longest diameter of the primary eligible lesion, and 4) Sum of longest diameter of all eligible lesions.

US Biotest, Inc.

NanOlogy, LLC

AEs were collected at all study visits from the time of first study drug application. Study personnel were required to review the Subject's diary at each visit to confirm it was adequately completed and to address and document discrepancies, missing entries and errors. Study personnel also asked open-ended questions to obtain information about AEs at every visit.

0.15% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 0.15%

1.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 1.0%

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 2.0% Group A

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 2.0% Group B

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Body Mass Index

The ECOG performance status scale is a measurement that describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. The scale ranges from 0 to 5, with a lower score indicating a more functional patient and a higher score indicating a patient with more negative impacts to their daily functions.

ECOG Performance Status

All enrolled subjects are included in the baseline analysis population.

Gere diZerega, MD

All subjects who received SOR007 were included in the analysis population.

Incidence of Treatment Emergent Adverse Events

Of the 23 Subjects enrolled, evaluable photography 14 days after the last dose of SOR007 was provided in 14 (60.9%) Subjects; two in the 0.15% treatment group, three in the 1.0% treatment group, four in 2.0% A treatment group, and five in 2.0% B treatment group.

Objective Clinical Response

Baseline (Day 1)

2 Weeks after Last Dose (Day 43 for 28-day treatment groups or Day 70 for 56-day treatment groups)

Change in Pain at the Treatment Area

Based on Area of the Primary Eligible Lesion

Based on Total Area of all Eligible Lesions

Based on Longest Diameter of the Primary Eligible Lesion

Based on Total Longest Diameter of all Eligible Lesions

2.0% SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment applied topically twice daily for 28 days or up to 56 days

SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment: One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.

SOR007 2.0%

One subject in SOR007 2.0% Group A was not included in the analysis.

Objective Tumor Response (OTR)

Overall Study

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

Anti-Infective Agents

Vaccines

Immunomodulating Agents

Imiquimod

Immunologic Factors

Adjuvants, Immunologic

Interferons

imiquimod

indocyanine green solution

flow cytometry

immunologic technique

laboratory biomarker analysis

Mark Naylor, MD

RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.

OBJECTIVES:

Primary

* Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared laser therapy with or without indocyanine green in patients with stage III or IV melanoma and cutaneous metastases.
* Determine the complete systemic and local response rates in patients treated with this regimen.

Secondary

* Determine the effect of this treatment on immunologic parameters in these patients.

OUTLINE: This is a prospective, open-label, pilot study.

Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and 28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by flow cytometry), and antibody response (by western blot).

After completion of study treatment, patients are followed monthly for 3 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin

Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

University of Oklahoma

Breast Diseases

Bleomycin

Electrochemotherapy is given as early as possible after the discovery of skin metastases

patients are to be treated for their breast cancer according to clinical routine with electrochemotherapy as an option only after 6 months from randomization

Electrochemotherapy

Jeffrey R Yachnin, MD, PhD

Electroporation combined with chemotherapy (ECT) has been shown to be an effective treatment for breast cancer that has spread to skin. In routine clinical practise, ECT is offered to patients when all other treatment options have been exhausted. This study tests the hypothesis that early treatment with ECT may result in improved local control of skin metastases, improved quality of life and reduced health care costs. Patients are randomised to either ECT given as early as possible in the course of the disease or delaying ECT for at least 6 months.

Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin

An International Randomized Phase II Study Comparing Early Electrochemotherapy to Delayed or No Electrochemotherapy in Patients With Cutaneous Breast Cancer Metastases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
Study of Topical SOR007 Ointment for Cutaneous Metastases	NCT03101358	Cutaneous Metas...	SOR007 (Uncoate...	18 Years -	NanOlogy, LLC
Study of Topical SOR007 Ointment for Cutaneous Metastases	NCT03101358	Cutaneous Metas...	SOR007 (Uncoate...	18 Years -	NanOlogy, LLC
Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin	NCT00453050	Melanoma (Skin) Metastatic Canc...	imiquimod indocyanine gre... flow cytometry immunologic tec... laboratory biom...	18 Years -	National Cancer Institute (NCI)
Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin	NCT00453050	Melanoma (Skin) Metastatic Canc...	imiquimod indocyanine gre... flow cytometry immunologic tec... laboratory biom...	18 Years -	National Cancer Institute (NCI)
Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin	NCT01479946	Breast Cancer Skin Metastases	Electrochemothe...	18 Years -	Uppsala University Hospital
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin	NCT01479946	Breast Cancer Skin Metastases	Electrochemothe...	18 Years -	Uppsala University Hospital
Electrochemotherapy For The Treatment Of Breast Cancer That Has Spread to the Skin	NCT01479946	Breast Cancer Skin Metastases	Electrochemothe...	18 Years -	Uppsala University Hospital
Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer	NCT00021424	Head and Neck C... Metastatic Canc...	recombinant fow...	18 Years -	National Cancer Institute (NCI)
Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma	NCT00862901	Breast Cancer Skin Cancer	CLIPT patch	18 Years -	Tufts Medical Center
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases	NCT00028652	Metastatic Canc...	interleukin-12 ...	18 Years - 120 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for skin metastases