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MelanomaPhase 3NCT00002882

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

A Phase 3 study testing Aldesleukin (IL-2), Recombinant Interferon Alfa (IFN-A) and Cisplatin in people with Melanoma and Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 10 to 70 years
Conditions the study is for
Melanoma, Skin Cancer
What is being tested?
Aldesleukin (IL-2), Recombinant Interferon Alfa (IFN-A) and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
Nov 1995to Apr 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2

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.

Read the detailed description

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.

Being tested
Aldesleukin (IL-2), Recombinant Interferon Alfa (IFN-A), Cisplatin, Dacarbazine, Vinblastine
Keywords
stage III melanoma
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aldesleukin (IL-2)Biological

    Also called IL-2, Interleukin-2, Proleukin

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

  • Recombinant Interferon Alfa (IFN-A)Biological

    Also called interferon alfa-2b, 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

  • CisplatinDrug

    Also called CDDP, Platinol, Platinol-AQ

    IV Days 1-4

  • DacarbazineDrug

    Also called DTIC

    IVPB on day 1

  • VinblastineDrug

    Also called Velban

    IVPB on days 1-4

  • Adjuvant TherapyProcedure or surgery

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

Study groups in NCT00002882
Study groupRoleWhat they receive
IFN-A Therapy Schedule AExperimentalSchedule 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.
Receives: Biological: Recombinant Interferon Alfa (IFN-A)
IFN-A Therapy Schedule BExperimentalSchedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.
Receives: Biological: Recombinant Interferon Alfa (IFN-A)
Adjuvant BiochemotherapyExperimentalCisplatin 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.
Receives: Biological: Aldesleukin (IL-2); Biological: Recombinant Interferon Alfa (IFN-A); Drug: Cisplatin; Drug: Dacarbazine; Drug: Vinblastine; Procedure: Adjuvant Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1995
  3. Primary completionAug 2003
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002882
Sponsor's protocol ID
ID95-196
Other IDs
P30CA016672, MDA-ID-95196, MDA-DM-95196, NCI-G96-1089, CDR0000065188
Status last verified
Dec 2011
First submitted
1 Nov 1999
Last updated
13 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19430405

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aldesleukin (IL-2), Recombinant Interferon Alfa (IFN-A) and Cisplatin in people with Melanoma and Skin Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Interferon Alfa with/without Combination Chemotherapy + Interleukin-2 for Melanoma (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.

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