Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Adesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CCCGHS-NCI-T98-0085 NCI-T98-0085, NCI-99-C-0051B, T98-0085, NCT00019682

Objectives

1. Compare the efficacy of high-dose aldesleukin (IL-2) with or without gp100 antigen with regard to clinical response in patients with locally advanced or metastatic cutaneous melanoma.
2. Compare the toxic effects of these 2 regimens in these patients.
3. Compare the disease-free and progression-free survival of patients treated with these 2 regimens.
4. Determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment.
5. Evaluate the quality of life of these patients before and after the first course of high-dose IL-2.

Entry Criteria

Disease Characteristics:

• Histologically proven locally advanced stage III or stage IV cutaneous melanoma
  • No ocular or mucosal melanoma



• Measurable disease



• HLA-A0201 positive



• No brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior biologic therapy
• No prior high-dose aldesleukin (600,000 IU/kg or more)
• No prior gp100 vaccines
• No other concurrent biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• At least 4 weeks since prior systemic steroids
• At least 2 weeks since prior topical or inhalational steroids
• No concurrent steroid therapy or steroid-like compounds

Radiotherapy:

• At least 4 weeks since prior radiotherapy to any site
• No concurrent radiotherapy to any site

Surgery:

• Prior surgery allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Greater than 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 90,000/mm³
• No coagulation disorder

Hepatic:

• Bilirubin no greater than 1.6 mg/dL
• AST or ALT less than 3 times normal
• No hepatitis B or C

Renal:

• Creatinine no greater than 1.6 mg/dL

Cardiovascular:

• No prior cardiac ischemia, myocardial infarction, or cardiac arrhythmias
• Normal stress cardiac test (e.g., stress thallium or stress MUGA)

Pulmonary:

• No prior obstructive or restrictive pulmonary disease
• FEV₁ at least 65%

  OR

• FVC at least 65%

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No active systemic infections
• No autoimmune disease
• No history of other major medical illnesses (e.g., insulin-dependent diabetes mellitus or inflammatory bowel disorder)
• No significant psychiatric disease
• No primary or secondary immunodeficiency

Expected Enrollment

A total of 93-185 patients (46-93 per treatment arm) will be accrued for this study within 2 years.

Outcomes

Whether the addition of peptide vaccine to high-dose aldesleukin is superior to alaldesleukin alone by response rates after each course of treatment

Toxicity of treatment by NCI Common Toxicity Criteria after each course of treatment
Disease-free and progression-free survival comparison by disease evaluation every 3 months after treatment
Immunologic response to treatment by various laboratory studies before and after each course of treatment
Quality of life by Functional Assessment of Chronic Illness Therapy Fatigue Subscale RSF-36 SDS before and after the first course of treatment

Outline

This is a randomized, multicenter study. Patients are stratified according to disease site (cutaneous or subcutaneous only vs any other site with or without subcutaneous disease).

Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses.



• Arm II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day 1. Patients also receive IL-2 as in arm I beginning on day 2.

In both arms, treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Quality of life is assessed before and after the first course of IL-2.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Center for Cancer Care at Goshen General Hospital

Douglas Schwartzentruber, MD, Protocol chair		Ph: 574-535-2893; 866-711-2888
Daniel Bruetman, MD, Protocol co-chair		Ph: 574-535-2888; 866-711-2888 Email: dbruetma@goshenhealth.com

Registry Information
Official Title		A Phase III Multi-Institutional Randomized Study of Immunization with the GP100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma
Trial Start Date		2000-06-14
Trial Completion Date		2002-05-08 (estimated)
Registered in ClinicalTrials.gov		NCT00019682
Date Submitted to PDQ		1999-03-10
Information Last Verified		2009-08-07

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