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Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
sargramostim
adjuvant therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III or IV disease No primary ocular melanoma Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible Patients whose second evaluation shows disease progression are eligible unless one of the following is true: Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN) LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy Patient has developed a new tumor measuring > 1 cm in diameter Sum of the longest diameters of the existing tumor has increased > 20% Evaluable or measurable disease Not potentially curable by surgery No active CNS metastases Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry PATIENT CHARACTERISTICS: Age 16 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 No active bleeding Hepatic See Disease Characteristics Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 1.2 mg/dL Cardiovascular Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following: Normal exercise stress test Normal stress thallium test Normal comparable cardiac ischemia evaluation LVEF ≥ 40% Other No active infection requiring treatment No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent antineoplastic biologic response modifier therapy No concurrent antineoplastic vaccine therapy Chemotherapy See Disease Characteristics No concurrent antineoplastic chemotherapy Endocrine therapy No concurrent steroidal antiemetics No concurrent systemic corticosteroids Radiotherapy See Disease Characteristics No concurrent antineoplastic radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Surgery within the past 4 weeks allowed provided there is no evidence of disease progression Other More than 4 weeks since prior therapy for melanoma No other concurrent antineoplastic experimental therapy

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
December 11, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085579
Brief Title
Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title
A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
Detailed Description
OBJECTIVES: Primary Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF). Secondary Determine the time to progression in patients treated with this regimen. Determine the effects of this regimen on lymphocyte subsets in these patients. OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease [SD] vs partial response [PR]). Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12. NOTE: *Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course. PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III or IV disease No primary ocular melanoma Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible Patients whose second evaluation shows disease progression are eligible unless one of the following is true: Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN) LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy Patient has developed a new tumor measuring > 1 cm in diameter Sum of the longest diameters of the existing tumor has increased > 20% Evaluable or measurable disease Not potentially curable by surgery No active CNS metastases Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry PATIENT CHARACTERISTICS: Age 16 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 No active bleeding Hepatic See Disease Characteristics Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 1.2 mg/dL Cardiovascular Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following: Normal exercise stress test Normal stress thallium test Normal comparable cardiac ischemia evaluation LVEF ≥ 40% Other No active infection requiring treatment No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent antineoplastic biologic response modifier therapy No concurrent antineoplastic vaccine therapy Chemotherapy See Disease Characteristics No concurrent antineoplastic chemotherapy Endocrine therapy No concurrent steroidal antiemetics No concurrent systemic corticosteroids Radiotherapy See Disease Characteristics No concurrent antineoplastic radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Surgery within the past 4 weeks allowed provided there is no evidence of disease progression Other More than 4 weeks since prior therapy for melanoma No other concurrent antineoplastic experimental therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul B. Chapman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jedd D. Wolchok, 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
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

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