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Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

Primary Purpose

Melanoma, Skin Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin, Vinblastine, Temozolomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring skin cancer, CISPLATIN, TEMOZOLOMIDE, VINBLASTINE, 09-017

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologic proof of melanoma reviewed and confirmed at MSKCC
  • Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
  • Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
  • No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
  • No other concurrent chemotherapy, immunotherapy, or radiotherapy
  • ECOG performance status ≤ 1
  • Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault).
  • Adequate cardiac function to tolerate the hydration needed for cisplatin administration.

Exclusion Criteria:

  • History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
  • Uveal melanoma primary
  • Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
  • Frequent vomiting or medical conditions that could interfere with oral medication intake
  • Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
  • History of HIV infection even if on HAART
  • Immunosuppressive drugs
  • High dose vitamins and herbs
  • Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

This is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy.

Outcomes

Primary Outcome Measures

Overall Response to CVT Chemotherapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Full Information

First Posted
April 21, 2009
Last Updated
April 21, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00885534
Brief Title
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Official Title
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Skin Cancer
Keywords
skin cancer, CISPLATIN, TEMOZOLOMIDE, VINBLASTINE, 09-017

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
This is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Vinblastine, Temozolomide
Intervention Description
Patients will receive CVT chemotherapy which consists of the following: Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.
Primary Outcome Measure Information:
Title
Overall Response to CVT Chemotherapy.
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Histologic proof of melanoma reviewed and confirmed at MSKCC Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible. Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate. No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed. No other concurrent chemotherapy, immunotherapy, or radiotherapy ECOG performance status ≤ 1 Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault). Adequate cardiac function to tolerate the hydration needed for cisplatin administration. Exclusion Criteria: History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months. Uveal melanoma primary Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease. Frequent vomiting or medical conditions that could interfere with oral medication intake Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy. History of HIV infection even if on HAART Immunosuppressive drugs High dose vitamins and herbs Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chapman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

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