Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Dacarbazine

Antineoplastic Agents, Alkylating

Alkylating Agents

30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks

rIL-21

Teresa Petrella

Kerry Savage

The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment.

This research is being done because currently there is no effective treatment for this type of cancer.

Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

A Randomized Phase II Study of Interleukin-21 (rIL-21) Versus Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.

Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures \< 10 mm (Note: continue to record the measurement even if \< 10 mm and considered CR). Residual lesions (other than nodes \< 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.

For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.

To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.

NCIC Clinical Trials Group

All grade 3 4 5 Adverse Events (5% or higher) were reported. All Serious Adverse Events were reported.

Spots Global Cancer Trial Database for Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial