Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

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

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Dacarbazine

Talimogene laherparepvec

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination occurs.

Subjects will receive (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination occurs.

PV-10 (10% rose bengal disodium)

Dacarbazine, temozolomide or talimogene laherparepvec

Eric Wachter, Ph.D.

Sanjiv Agarwala, M.D.

This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).

Subjects in the comparator arm who have completed at least 1 cycle of study treatment and who meet the study protocol definition of disease progression but do not have evidence of visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10. Subjects crossing over must meet all study inclusion and exclusion criteria for clinical laboratories, thyroid function, concurrent or intercurrent illness and pregnancy at the time of crossover.

Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include increase in size and/or number of lesions, distant or nodal disease progression, or death. All secondary endpoints involving disease response and progression will be based on the IRC determination.

An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.

Blinded review by independent review committee (IRC) for primary and key secondary endpoints.

PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

In this exploratory endpoint, changes in Skindex-16 self-assessment scores were evaluated vs Day 1 baseline domain scores: symptom domain (items 1-4); emotional domain (items 5-11); and functioning domain (items 12-16). The Skindex-16 instrument solicits response to the extent of bother during the preceding week by 16 items (e.g., itching, hurting, worry, impact on daily activities), using a score from 0 (never bothered) to 6 (always bothered) for each item. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. A lower domain score at baseline signifies lower impact of that domain; a decrease in domain score from baseline signifies improvement in that domain. Median baseline score and change from baseline over the study interval is presented for each domain.

PFS was estimated via Kaplan-Meier analysis using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Subjects who did not have an event of progression or death were censored at their last assessment date.

Assessment of progression was performed by the sponsor based on review of lesion measurement and clinical progression data reported by each investigator. Events signaling progression included increase in size and/or number of study lesions, onset of visceral metastatic disease, and death. For target lesions (assigned prior to randomization), complete response (CR) required disappearance of all target lesions; partial response (PR) required \>= 30% decrease in sum of the longest diameter (SLD) of all target lesions; progressive disease (PD) required \>=20% increase in SLD of target lesions. Non-target lesions were followed for CR, PD, or non-CR/non-PD status using equivalent thresholds. Progression occurred when PD was observed in either target or non-target lesion.

CRR was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.

DCR was estimated via Kaplan-Meier analysis for participants achieving a complete response, and was defined as the interval from first complete response to disease progression or death; responders who did not have an event of progression or death were censored at their last assessment date. Complete response was assessed using RECIST v1.1 criteria, and required disappearance of all target and non-target lesions.

OS was documented at 12 week intervals commencing on withdrawal from active study participation. Documentation was made by subject clinic visit or other personal contact, telephonic contact, review of medical records, or other unequivocal evidence of survival status. OS was estimated via Kaplan-Meier analysis, and was defined as the interval from randomization to death; subjects who did not have an event of death were censored at their last assessment date.

Safety and tolerability were assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.

Provectus Biopharmaceuticals, Inc.

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.

PV-10 (10% rose bengal disodium)

PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator

PV-10

Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.

Dacarbazine, temozolomide or talimogene laherparepvec

Chemotherapy or Oncolytic Viral Therapy

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 was re-administered at 28-day intervals until complete response, disease progression or study termination.

Subjects received (a) dacarbazine (intravenously at 850 m/m2) or temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), administered at consecutive 28-day intervals, or (b) intralesional talimogene laherparepvec administered on an initial 21 interval followed by consecutive 14 day intervals, until complete response, disease progression or study termination.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Italy

France

Region of Enrollment

Disease burden was assessed at baseline to characterize melanoma disease stage according to the AJCC 2009 staging system, where stage (I-IV) is based on TNM classification: T refers to tumor size, N refers to lymph node involvement, and M represents metastasis (spread) to other parts of the body. The staging number represents a sum of the TNM classification: a lower stage (i.e., I or II) represents better the prognosis for the patient; the higher the stage (i.e., III or IV), the worse the prognosis.

Participants were not stratified according to stage.

American Joint Committee on Cancer (AJCC) Stage at Baseline

Planned accrual was 225 subjects. However, due to slow accrual during a period of rapid change in global drug development for cutaneous melanoma, the study was terminated early after 20 subjects initiated study treatment. Because the study was terminated prior to achievement of pre-specified efficacy thresholds, the planned central independent review was not conducted and the small number of subjects precluded formal analysis and scientifically meaningful interpretation of efficacy parameters.

Eric Wachter, Chief Technology Officer

Subjects received intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at 28-day intervals until complete response, disease progression or study termination.

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of PFS.

Progression-free Survival (PFS)

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of CRR.

Complete Response Rate (CRR)

Subjects receiving PV-10 upon crossover from comparator are not included in the analysis population.

Response data from one study center were censored due to resignation of the principal investigator.

Duration of Complete Response (DCR)

Subjects were analyzed according to treatment group assignment at randomization.

Overall Survival (OS)

PV-10 safety population includes two subjects who received PV-10 upon crossover after progression on comparator.

Number of Participants With Adverse Events

Baseline Symptom Domain Score

Change in Symptom Domain Score from Baseline

Baseline Emotional Domain Score

Change in Emotional Domain Score from Baseline

Baseline Functioning Domain Score

Change in Functioning Domain Score from Baseline

Subjects receiving PV-10 upon crossover from comparator are included in the analysis population for PV-10 (after crossover).

Response data from one study center were censored due to resignation of the principal investigator.

Because the study was terminated prior to achievement of pre-specified efficacy thresholds (i.e., out of a planned 225 subjects only 20 initiated study treatment), the small number of subjects enrolled precludes scientifically meaningful interpretation of Skindex data.

Change in Domain Scores From Baseline Using the Patient Reported Skindex-16 Instrument

PV-10 (10% Rose Bengal Disodium)

Chemotherapy or Oncolytic Viral Therapy (Dacarbazine, Temozolomide or Talimogene Laherparepvec)

Overall Study

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Micronutrients

Hematinics

Vitamins

Herbal and Botanical

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Topoisomerase I Inhibitors

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Cola

every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started

every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion

Folfox Protocol

Jaafar BENNOUNA, Professor

Julien TAIEB, Professor

Thierry ANDRE, Professor

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association of 5-fluorouracil (5-FU), folinic acid, irinotecan, and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, and 5-FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

After inclusion and non-inclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized in the trial. The maximum delay allowed between the signature of the consent form by the patient and the randomization in the study is 28 days.

The randomization procedure using minimization method will allocate the treatments mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio, and will be stratified by the following criteria:

* Perforation or urgent surgery versus no perforation and no urgent surgery.
* T1-T3N2 vs T4aN1 versus T4bN1 versus T4N2.
* Right colon (right of splenic flexure) vs left colon.
* Country (France vs Canada vs Italy). Patient eligible and who have signed the informed consent will be randomized in one of the two treatments arms and will receive every 14 days their treatment for a duration of 12 cycles.

Arm A: mFOLFIRINOX Arm B: mFOLFOX 6

The trial is a phase III, multicenter, open-labeled randomized trial comparing the association 5-fluorouracil, folinic acid, irinotecan and oxaliplatin (mFOLFIRINOX) versus oxaliplatin, folinic acid, 5FU (mFOLFOX 6) chemotherapy protocols in patients with high-risk stage III colon cancer in the adjuvant setting.

The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:

* first local, regional or distant relapse;
* second colorectal cancer;
* death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.

IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for High-risk Stage III Colon Cancer in Adjuvant Setting

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

DFS :

defined as the time from the date of randomization up to the date of:

* first local, regional or distant relapse;
* second colorectal cancer;
* death from any cause included treatment-related death.

Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause

Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.

The following parameters will be particularly followed:

The incidence of haematological toxicities (grade 3-4, in particular neutropenia and febrile neutropenia); The incidence of GI toxicities, in particular diarrhea; The incidence of peripheral neuropathy.

Canadian Cancer Trials Group

GONO GROUP

UNICANCER

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

Small Cell Lung Cancer

Cisplatin

Cisplatin (150 mg/m\^2) is given as an intra-arterial bolus, once, on days 2 and 9 of treatment. Thiosulfate (9 g/m\^2), is given concurrently with cisplatin as an intravenous push over 15-20 minutes followed by a 6-hour intravenous infusion of thiosulfate (12 g/m\^2).

Cisplatin, Thiosulfate

Gregory Daniels, M.D.

This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2 consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. This pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin.

If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.

Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases

A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases

To characterize the toxicity of intra-arterial supradose cisplatin with thiosulfate rescue when delivered as two doses, one week apart, for patients with primary lung tumors and/or lung metastases.

University of California, San Diego

Professor

Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.

DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Allovectin-7®

1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR

Dacarbazine (DTIC)

150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Temozolomide (TMZ)

Linda Strause, PhD

To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

Vical

Sarcoma

Histiocytoma, Malignant Fibrous

Histiocytoma

Neoplasms, Connective and Soft Tissue

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma

Antibodies

Nivolumab

Immunoglobulins

Immune Checkpoint Inhibitors

Phase 1: All patients will receive BA3011, CAB-AXL-ADC.

Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma	NCT02288897	Cutaneous Melan...	PV-10 (10% rose... Dacarbazine, te...	18 Years -	Provectus Pharmaceuticals
IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting	NCT02967289	Colon Cancer (H...	Irinotecan Folfox Protocol	18 Years - 75 Years	UNICANCER
IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting	NCT02967289	Colon Cancer (H...	Irinotecan Folfox Protocol	18 Years - 75 Years	UNICANCER
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases	NCT01114958	Lung Neoplasms Neoplasm Metast...	Cisplatin, Thio...	18 Years -	University of California, San Diego
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma	NCT00395070	Metastatic Mela...	Allovectin-7® Dacarbazine (DT... Temozolomide (T...	18 Years -	Vical
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases	NCT01114958	Lung Neoplasms Neoplasm Metast...	Cisplatin, Thio...	18 Years -	University of California, San Diego
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma	NCT03425279	Undifferentiate... Myxofibrosarcom...	CAB-AXL-ADC PD-1 inhibitor	12 Years -	BioAtla, Inc.
Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma	NCT01496807	Melanoma	Sylatron Yervoy	16 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for stage 3

Every month we try and update this database with for stage 3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stage 3

Every month we try and update this database with for stage 3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stage 3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.