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
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Paul B. Chapman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
04-027
NCT ID:
NCT00085579
Start Date:
March 2004
Completion Date:
March 2005
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
