Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-11-30

Study Completion Date

2006-04-30

Brief Summary

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RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.

Detailed Description

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OBJECTIVES:

* Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A) administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected.
* Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and their effect on the quality of life.
* Determine the prognostic value of detection of melanoma cells in the peripheral blood using RT/PCR for tyrosinase mRNA.

OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors.

Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy.

Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules.

* Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
* Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. Adjuvant biochemotherapy begins immediately after registration on the study. Cisplatin is given IV on days 1-4; vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.

Conditions

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Melanoma Skin Cancer

Keywords

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stage III melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IFN-A Therapy Schedule A

Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Group Type EXPERIMENTAL

Recombinant Interferon Alfa (IFN-A)

Intervention Type BIOLOGICAL

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

IFN-A Therapy Schedule B

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.

Group Type EXPERIMENTAL

Recombinant Interferon Alfa (IFN-A)

Intervention Type BIOLOGICAL

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Adjuvant Biochemotherapy

Cisplatin IV Days 1-4; Vinblastine IVPB Days 1-4; Dacarbazine (DTIC) IVPB on Day 1; IFN-A is given subcutaneously on days 1-5; IL-2 continuous infusion for 96 hours on Days 1-4. Each course repeated every 21 days for 4 courses.

Group Type EXPERIMENTAL

Aldesleukin (IL-2)

Intervention Type BIOLOGICAL

Infusion for a total of 96 hours on days 1-4

Recombinant Interferon Alfa (IFN-A)

Intervention Type BIOLOGICAL

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Cisplatin

Intervention Type DRUG

IV Days 1-4

Dacarbazine

Intervention Type DRUG

IVPB on day 1

Vinblastine

Intervention Type DRUG

IVPB on days 1-4

Adjuvant Therapy

Intervention Type PROCEDURE

Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

Interventions

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Aldesleukin (IL-2)

Infusion for a total of 96 hours on days 1-4

Intervention Type BIOLOGICAL

Recombinant Interferon Alfa (IFN-A)

IFN-A Therapy Groups:

Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.

Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks

Adjuvant Biochemotherapy Group: IFN-A is given subcutaneously on days 1-5

Intervention Type BIOLOGICAL

Cisplatin

IV Days 1-4

Intervention Type DRUG

Dacarbazine

IVPB on day 1

Intervention Type DRUG

Vinblastine

IVPB on days 1-4

Intervention Type DRUG

Adjuvant Therapy

Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy.

Intervention Type PROCEDURE

Other Intervention Names

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IL-2 Interleukin-2 Proleukin interferon alfa-2b IFN-A CDDP Platinol Platinol-AQ DTIC Velban

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically diagnosed malignant melanoma with regional lymph node metastases
* Undergone complete lymph node dissection and free of any residual tumor
* No greater than 90 days from diagnosis of regional lymph nodes metastases
* No distant or resected in-transit metastases

PATIENT CHARACTERISTICS:

Age:

* 10 to 66
* 66 to 70 if in excellent physical condition

Performance status:

* 0-2

Life expectancy:

* At least 12 months

Hematopoietic:

* Hemoglobin greater than 10 g/dL
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.2 mg/dL

Renal:

* Creatinine no greater than 1.5 mg/dL

Other:

* No serious intercurrent illness that would compromise tolerance of therapy and long term survival
* Must be able to participate in follow up for minimum of 5 years
* No second malignancy except:

* In situ cervical cancer
* Basal or squamous skin cancer
* Must be able to physically and emotionally tolerate biochemotherapy
* No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy with interferon or IL-2
* No concurrent immunomodulators

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* No concurrent steroids

Radiotherapy:

* Prior adjuvant local radiotherapy allowed for head and neck

Surgery:

* No greater than 8 weeks after definitive surgery for lymph node metastases

Other:

* No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agop Y. Bedikian, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Kim KB, Legha SS, Gonzalez R, Anderson CM, Johnson MM, Liu P, Papadopoulos NE, Eton O, Plager C, Buzaid AC, Prieto VG, Hwu WJ, Frost AM, Alvarado G, Hwu P, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, Benjamin RS, Bedikian AY. A randomized phase III trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res. 2009 Feb;19(1):42-9. doi: 10.1097/CMR.0b013e328314b84a.

Reference Type RESULT

PMID: 19430405 (View on PubMed)