SWOG clinical trial number
S0026

Evaluation of Interferon Alpha-2b and Thalidomide in Patients with Disseminated Malignant Melanoma, Phase II

Closed
Phase
Accrual
62%
Published
Abbreviated Title
IFN & Thalidomide in Disseminated Malignant Melanoma
Activated
11/01/2001
Closed
05/01/2003
Participants
NCORP, Members, Medical Oncologists

Research committees

Melanoma

Treatment

Thalidomide Interferon alpha-2b

Eligibility Criteria Expand/Collapse

Pts. must have histologically proven, pathologically verified and surgically incurable malignant melanoma, Stage IV; pts. must have measurable or non-measurable disease by CT, MRI, X-Ray or physical exam; CT or MRI of brain must be negative for mets; history of brain mets allowed only if completely resected and completely free of disease after whole brain XRT; pts. must have received only one prior systemic therapy (chemo, biologic/immuno, hormone or combination regimen) for metastatic dz; pts. must have recovered from all adverse effects of prior treatment(s) prior to registration; SGOT and/or SGPT <= 2.5 IULN and bilirubin <= IULN; ANC >= 1,000 and platelets >= 75,000; Zubrod PS 0-2; pts. w/known AIDS or HIV-1 assoc. complex or known to be HIV sero+ are ineligible; pts. must not be pregnant or nursing, or of reproductive potential and not agreed to use effective contraceptive method; female pts. of childbearing potential must have a negative pregnancy test; pts. must not be planning to receive concomitant biologic therapy, RT, hormonal therapy, other chemo, surgery or other therapy while on study; pts. must not have prior malignancy other than adequately treated basal cell or squamous cell skin ca, in situ cervical ca, adequately treated Stage I or II ca from which the patient is currently in complete remission, or any ca from which the pt. has been disease-free for 5 yrs; pts. must not have >= Grade 1 "Neuropathy-sensory" according to the NCI CTC version 2.0; pts. must not have a history of seizures or a potential for the development of seizures.

Publication Information Expand/Collapse

2011

Benchmarks for evaluating phase II clinical trials in stage IV melanoma: the recent SWOG experience

V Sondak;M Othus;L Flaherty;B Redman;J Moon;K Margolin;C Lao;W Carson;A Ribas International Melanoma Congress, abstract 50; 8th Annual Meeting, Nov 9-11, 2011, Tampa, Fl; oral presentation

2007

Evaluation of interferon alpha-2b and thalidomide in patients with disseminated malignant melanoma, phase 2, SWOG 0026

LF Hutchins;J Moon;JI Clark;JA Thompson;MK Lange;LE Flaherty;VK Sondak Cancer 110(10):2269-2275

PMid: PMID17932881

2004

Interferon Alpha-2b and thalidomide in previously treated patients with disseminated malignant melanoma: SWOG 0026

L Hutchins;J Moon;J Clark;J Thompson;K Yost;V Sondak Proc of the American Society of Clinical Oncology 23:713 (#7527)

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