Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

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

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.

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

Relevance to patient case: not relevant