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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

Phase 2
16 Years
Not Enrolling
Melanoma (Skin)

Thank you

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



- 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).


- 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

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

Inclusion Criteria


- 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

- 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



- 16 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified


- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- No active bleeding


- See Disease Characteristics

- Bilirubin ≤ 2.0 mg/dL


- Creatinine ≤ 1.2 mg/dL


- 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%


- 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


Biologic therapy

- No other concurrent antineoplastic biologic response modifier therapy

- No concurrent antineoplastic vaccine therapy


- See Disease Characteristics

- No concurrent antineoplastic chemotherapy

Endocrine therapy

- No concurrent steroidal antiemetics

- No concurrent systemic corticosteroids


- See Disease Characteristics

- No concurrent antineoplastic radiotherapy


- See Disease Characteristics

- Recovered from prior surgery

- Surgery within the past 4 weeks allowed provided there is no evidence of disease


- More than 4 weeks since prior therapy for melanoma

- No other concurrent antineoplastic experimental therapy

Type of Study:


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


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

March 2005

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • Melanoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021