Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

NCT00553618 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 07.0008
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective treatment for melanoma than currently available treatments for people with high-risk melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the treatment of melanoma.

Conditions

Metastatic Melanoma

Keywords

Interleukin 2; Proleukin; DTIC; Dacarbazine; metastatic melanoma; adjuvant

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

  The study duration is projected to be approximately 9 years

Study Arms (1)

Proleukin/DTIC Arm

EXPERIMENTAL

Adjucant proleukin and DTIC

Drug: Proleukin and Dacarbazine

Interventions

Proleukin and Dacarbazine DRUG

IL-2 (Proleukin), injected just under the skin, at a dose of 12 million units on days 1-4 for each of the six months of therapy. Dacarbazine, administered as an IV infusion through a freely flowing IV, at a dose of 750 mg, repeated every four weeks.

Also known as: Proleukin, Dacarbazine

Proleukin/DTIC Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must fulfill one of the following criteria:
• T4 NO MO - Deep primary melanoma (\> 4.0 mm) with or without lymphadenectomy.
• T1-4 N1-3 MO - Primary melanoma with regional lymph node metastases found at lymphadenectomy or sentinel lymph node sampling, but clinically undetectable (occult).
• T1-4 N1-3 MO - Primary melanoma with clinically apparent (overt) regional lymph node metastases confirmed by lymphadenectomy.
• T1-4 N1-3 MO - Recurrence of melanoma at the proximal regional lymph node(s).
• Patients must have undergone a wide excision of the primary and, if \>1mm in depth, have completed sentinel lymph node sampling or lymphadenectomy as is standard of practice. Patients must have confirmation of adequate surgical margins around the primary lesion (1 or 2 cm minimum, for primary lesions of 1-2 mm depth; 2 cm for primary lesions equal to or greater than 2 mm depth). When entering this study with recurrent regional lymph node disease, the patient must be enrolled no later than 90 days from the date of lymphadenectomy.
• For subungual melanomas a distal interphalangeal. amputation is required. For patients with regional lymph node recurrence, the same evidence for adequate margins around the primary are required as for patients at initial presentation.
• For safety reasons, patients must be of age between 18 and 85.
• Patients must have ECOG performance status 0-2.
• Patients must have WBC \>3,000, platelet count \>100,000, and hematocrit \>33.
• Patients must have SGOT and bilirubin \<2x normal; creatinine \<2.3; BUN \<33.
• Patients must have no active medical or psychiatric disorders requiring therapy that would prevent completion of the protocol.
• Patients must give written informed consent.

You may not qualify if:

• Patients for whom histopathologic examination of the primary or metastatic melanoma is not positive are ineligible.
• Patients who have clinical, radiological, laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease are ineligible.
• Patients with an active second cancer (except in situ cervical cancer, or basal or squamous skin cancer) are ineligible. Exceptions may be discussed with the principal investigator.
• Patients with organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, are ineligible.
• Patients who have had prior adjuvant chemotherapy, immunotherapy, including preoperative infusion or perfusion therapy are ineligible.
• Patients with recurrent melanoma at regional lymph nodes must not have been previously entered into this study.
• Patients with more than one lymph node group involved are ineligible.
• Women of child bearing age who are not on adequate birth control are ineligible.
• Women who are pregnant or breast feeding are ineligible.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Links

• James Graham Brown Cancer Center, Louisville, KY

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jason A Chesney, MD

  James Graham Brown Cancer Center, University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, James Graham Brown Cancer Center

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 5, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (1)