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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00553618
First received: November 1, 2007
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma
Drug: Proleukin and Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazole-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Relapse-free survival [ Time Frame: The study duration is projected to be approximately 4 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2007
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proleukin/DTIC Arm
Adjucant proleukin and DTIC
Drug: Proleukin and Dacarbazine

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.

Other Name: Proleukin, Dacarbazine

Detailed Description:

The prognosis of patients with malignant melanomas that are greater than 4 mm deep or involve regional lymph nodes is poor, even after successful surgical removal. The concept of adjuvant therapy for melanoma is derived from the hypothesis that these therapies may kill micro-metastatic seeds of melanoma cells.

The rationale for this particular drug combination regimen is that melanoma cells may act as a vaccine from which to generate melanoma-specific T cell expansion by way of IL2 administration. In unpublished results, forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval. Analysis of relapse free survival and overall survival in patients treated with this combination suggested a small improvement in disease-free survival when compared to historical controls or another study whose patients had similar but not identical staging (median follow-up time of 30 months). Importantly, no unanticipated side effects were observed as a result of the combination of these two drugs (both of which are FDA-approved for use in melanoma patients).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553618

Contacts
Contact: Jason A Chesney, MD 502-562-4370

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christy LaDuke, BS    502-562-3429      
Sub-Investigator: Kelly M McMasters, MD         
Sub-Investigator: Donald M Miller, MD         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Jason A Chesney, MD James Graham Brown Cancer Center, University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00553618     History of Changes
Other Study ID Numbers: 07.0008
Study First Received: November 1, 2007
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
Interleukin 2
Proleukin
DTIC
Dacarbazine
metastatic melanoma
adjuvant

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Dacarbazine
Aldesleukin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014