High-Dose Interferon Alfa in Treating Patients With Stage II or StageIII Melanoma

Hackensack Meridian Health

Status and phase

Withdrawn

Phase 3

Conditions

Melanoma (Skin)

Treatments

Drug: recombinant interferon alfa

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00447356

E1697 (Other Identifier)

Details and patient eligibility

About

This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

Full description

Interferon alfa may interfere with growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed primary melanoma of cutaneous origin
Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
Clinically negative regional lymph node pathologic status unkown OR
Histologically negative regional lymph nodes
Stage III (T4 N0 M0)
Greater than 4.0mm Breslow depth OR
Stage III (T1-4 N1)
One lymph node positive microscopically
Patients must meet at least 1 of the following criteria
T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node negative
T4a-b N0 primary melanoma > 4.0mm with and without ulceration, node negative
T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically positive lymph node (any number)
Note EORTC patients who are node negative T2 or T3 are ineligible
Patients with positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in the study within 84 days of wide excision
No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
No clinically palpable lymphadenopathy

Age:

18 and over

Performance Status:

ECOG 0-1

Life expectancy:

Not specified Hematopoietic
WBC at least 3,000/mm^3
Platelet count at least 125,000/mm^3
Hematocrit at least 30%

Hepatic:

Bilirubin no greater than 2 times the upper limit of normal (ULN)
AST, LDH, and Alkaline phosphate no greater than 2 times ULN
If lactate dehydrogenase or alkaline phosphate is above normal, a contrast enhanced CT scan or MRI of the liver is required to document the absence of tumor

Renal:

BUN no greater than 33mg/dl OR
Creatinine no greater than 1.8mg/dl

Cardiovascular:

No history of active ischemic heart disease
No cerebrovascular disease
No congestive heart failure(New York Heart Association class III or IV heart disease)

Exclusion criteria

Biologic Therapy:

No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole, or other biologic response modifers for melanoma Chemotherapy
No prior or concurrent chemotherapy Endocrine Therapy
No concurrent systemic corticosteriods including oral steriods (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steriod-containing inhalers.

Radiotherapy:

No Prior or concurrent radiotherapy

Surgery:

See Disease characteristics

Other:

No other concurrent immunosuppressive medications
No other history of invasive melanoma
No autoimmune disorders or conditions of immunosuppression
No other concurrent or prior malignancies within past 5 years
Cancer in situ
Lobular carcinoma in situ of breast
Carcinoma in situ of the cervix
Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
Basal or squamous cell skin cancer
No evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
No other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation.
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study