Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed no age specified NCI-D78-026-202 RPMI-PPC-580

Objectives

I.  Evaluate the therapeutic efficacy of adjuvant chemotherapy with DTIC for 
patients previously untreated with DTIC or BCNU/actinomycin-D/vincristine 
following excisional surgery in patients with resectable Stage II-III (using a 
3-stage system) malignant melanoma.
II.  Evaluate the effect of combining anticoagulation therapy with 
chemotherapy.
III.  Determine the effectiveness of ia perfusion with melphalan in patients 
with intransit lesions in an extremity.
IV.  Assess the effect of early incontinuity resection of intransit lesions 
when combined with chemotherapy with or without anticoagulation.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with malignant melanoma 
Stage II or III of the 3-stage system in whom there is no contraindication to 
surgery or the prescribed chemotherapy.  Patients may not have conditions that 
render them unsuitable for anticoagulation (e.g., active peptic ulcer, brain 
metastases).

Expected Enrollment

Protocol closed.

Outline

Partially randomized study.  Enter patients with intransit extremity lesions 
to Regimen A and all others to Regimen B.  For adjuvant chemotherapy, assign 
patients who have not previously received DTIC to Regimen C and those with a 
history of prior DTIC treatment to Regimen D.  Patients in Regimens C and D 
will be randomized to receive or not to receive anticoagulation therapy 
concurrently with chemotherapy.
Regimen A:  Single-agent Local Arterial Perfusion Therapy.  Melphalan, L-PAM, 
NSC-8806.
Regimen B:  Surgery plus Intraoperative Single-agent Chemotherapy.  Excision 
plus intraoperative DTIC, NSC-45388.
Regimen C:  Single-agent Chemotherapy.  DTIC.
Regimen D:  3-Drug Combination Chemotherapy.  BCNU, NSC-409962; Vincristine, 
VCR, NSC-67574; Actinomycin-D, ACT-D, NSC-3053.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Philip Bonomi, MD, Protocol chair		Ph: 312-942-8312 Email: Philip_Bonomi@rsh.net