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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
dendritic cell-gp100-MART-1 antigen vaccine
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV metastatic melanoma Unresectable disease for which no other therapy exists Measurable or evaluable disease by clinical or radiographic evaluation Metastatic tumor tissue expressing both gp100 and MART-1 No uncontrolled or progressive CNS involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No clinically significant hematologic disorder Hepatic: Bilirubin less than 2.0 mg/dL No clinically significant hepatic disease Hepatitis B surface antigen negative Renal: Creatinine less than 2.0 mg/dL No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test HIV-1 and HIV-2 negative HTLV-1 negative No significant psychiatric disorder that would prevent compliance No underlying condition that would preclude study therapy No autoimmune disease or other major immune system illness No active infection requiring parenteral antibiotic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with vaccines directed at MART-1 or gp100 melanoma antigens Prior interleukin-2 or interferon therapy allowed Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery (except study biopsies) and recovered Other: At least 4 weeks since prior experimental therapy and recovered At least 4 weeks since prior immunosuppressive drugs and recovered No other concurrent experimental therapy or anti-cancer drugs No concurrent immunosuppressive therapy

Sites / Locations

  • Dana-Farber Cancer Institute
  • U.S. Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 3, 2014
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00004025
Brief Title
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Official Title
Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Unknown status
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed.
Detailed Description
OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma. II. Evaluate the cellular response and efficacy of these regimens in this patient population. OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
dendritic cell-gp100-MART-1 antigen vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV metastatic melanoma Unresectable disease for which no other therapy exists Measurable or evaluable disease by clinical or radiographic evaluation Metastatic tumor tissue expressing both gp100 and MART-1 No uncontrolled or progressive CNS involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No clinically significant hematologic disorder Hepatic: Bilirubin less than 2.0 mg/dL No clinically significant hepatic disease Hepatitis B surface antigen negative Renal: Creatinine less than 2.0 mg/dL No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test HIV-1 and HIV-2 negative HTLV-1 negative No significant psychiatric disorder that would prevent compliance No underlying condition that would preclude study therapy No autoimmune disease or other major immune system illness No active infection requiring parenteral antibiotic therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with vaccines directed at MART-1 or gp100 melanoma antigens Prior interleukin-2 or interferon therapy allowed Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery (except study biopsies) and recovered Other: At least 4 weeks since prior experimental therapy and recovered At least 4 weeks since prior immunosuppressive drugs and recovered No other concurrent experimental therapy or anti-cancer drugs No concurrent immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy E. Bock
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
U.S. Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77060
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

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