Overview

This trial is active, not recruiting.

Conditions metastatic melanoma, cutaneous melanoma
Treatments interferon alpha, kw2871
Phase phase 2
Sponsor Ludwig Institute for Cancer Research
Collaborator Life Sciences Pharmaceuticals
Start date March 2008
End date April 2015
Trial size 50 participants
Trial identifier NCT00679289, LUD2007-001, UCH15689B, UPCI07-023

Summary

This study will evaluate the safety and effectiveness of the combination regimen of KW2871 and high dose Interferon-alfa2b (HDI) in patients with metastatic melanoma (skin cancer that has spread to other parts of the body).

KW2871 is an antibody that is made in a laboratory. Antibodies are part of the immune system. KW2871 attaches to the GD3 ganglioside (a molecule that is found on melanoma cells). This may help slow or stop the growth of melanoma tumors.

Interferon-alfa 2b is a man-made version of interferon. Interferons are among a number of substances produced by the immune system in response to the presence of enemy cells. Not only does it "interfere" with foreign invaders that may cause infection, but it can prevent the growth and spread of other diseased cells as well, including some types of cancer cells. Interferons have been shown to be effective against a variety of tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
KW2871 (5 mg/m2) IV Q2W until disease progression Interferon alpha 20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression
interferon alpha Intron A
20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression
kw2871 Ecromeximab
5 mg/m2 IV Q2W until disease progression
(Experimental)
KW2871 10 mg/m2 IV Q2W until disease progression Interferon alpha 20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression
kw2871 Ecromeximab
10 mg/m2 IV Q2W until disease progression
interferon alpha Intron A
20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression
(Experimental)
KW2871 20 mg/m2 IV Q2W until disease progression Interferon alpha 20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression
kw2871 Ecromeximab
20 mg/m2 IV Q2W until disease progression
interferon alpha Intron A
20 MU/m2 IV QD x 5 Days for 4 weeks, then 10 MU/m2 SC TIW until disease progression

Primary Outcomes

Measure
Progression Free Survival
time frame: ongoing
Toxicity
time frame: Ongoing until disease progression

Secondary Outcomes

Measure
Tumor Response
time frame: Ongoing until disease progression
Antibody-dependent cell mediated cytotoxic (ADCC) activity and complement-dependent cytotoxic (CDC) activity
time frame: Ongoing until disease progression
Pharmacokinetic of KW2871 and the development of human antichimeric antibodies (HACA).
time frame: Ongoing until disease progression

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. >18 years of age 2. Histologically proven metastatic cutaneous, mucosal, or unknown primary melanoma 3. Measurable disease using response evaluation criteria in solid tumors RECIST criteria 4. Are ambulatory (ECOG performance status 0 or 1) or expected survival >/= 4 months 5. Within the last two weeks prior to study day 1, the following laboratory parameters should be within the ranges specified (Table 4): Table 4: Baseline peripheral laboratory values acceptable for enrollment - Hemoglobin >/= 9 g/dL - Platelets >/= 100 x 109/L - Neutrophil count >/= 1.5 x 109/L - INR

Additional Information

Official title Phase II Study of the Anti-Ganglioside GD3 Mouse/Human Chimeric Antibody KW2871 Combined With High Dose Interferon-alpha2b in Patients With Metastatic Melanoma
Description This is an open label study of KW2871 plus high dose IFN-α2b (HDI) in patients with measurable metastatic melanoma. All eligible patients will receive KW2871 IV every two weeks (Wednesday) starting on week 1. HDI will also be given at a dose of 20 MU/m2 IV for five consecutive days (Monday thru Friday) per week for four weeks, and then 10 MU/m2 sc three times a week (Monday, Wednesday, Friday). Patients will be treated with KW2871-HDI combination therapy until disease progression requiring treatment intervention that would interfere with the interpretation of the study results.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Ludwig Institute for Cancer Research.