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

Melanoma (Skin) Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00085579
• Other study ID #: 04-027
• Secondary ID: MSKCC-04027
• Status: Withdrawn
• Phase: Phase 2
• First received: June 10, 2004
• Last updated: December 11, 2012
• Start date: March 2004
• Est. completion date: March 2005

Study information

• Verified date: December 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• sargramostim

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,