CPG 7909 Injection in Melanoma

February 9, 2009 updated by: Pfizer

ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study

To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed melanoma that is metastatic.
  • Measurable disease according to the RECIST criteria.
  • Karnofsky Performance Status of > 70.

Exclusion Criteria:

  • Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
  • Suspected or known CNS metastases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPG 7909 Injection plus chemotherapy
CPG 7909 Injection plus DTIC
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Other Names:
  • ProMune, PF-03512676
Drug: dacarbazine
dacarbazine 850mg/m2 in three-week cycles until disease progression
Other Names:
  • DTIC
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
Other Names:
  • ProMune, PF-03512676
Active Comparator: Chemotherapy alone
dacarbazine
Drug: Chemotherapy

Chemotherapy in three-week cycles until disease progression:

dacarbazine 850mg/m2

Other Names:
  • DTIC
Experimental: CPG 7909 Injection 10 mg
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Other Names:
  • ProMune, PF-03512676
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
Other Names:
  • ProMune, PF-03512676
Experimental: CPG 7909 Injection 40 mg
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
Other Names:
  • ProMune, PF-03512676
Drug: CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
Other Names:
  • ProMune, PF-03512676

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
Time Frame: indeterminate
indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Time Frame: Indeterminate
Indeterminate

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase III: Assess the overall response rate
Time Frame: indeterminate
indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
Time Frame: indeterminate
indeterminate
Determine the duration of response.
Time Frame: indeterminate
indeterminate
Determine the time to progression
Time Frame: indeterminate
indeterminate
Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
Time Frame: indeterminate
indeterminate
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
Time Frame: indeterminate
indeterminate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 6, 2003

First Submitted That Met QC Criteria

October 7, 2003

First Posted (Estimate)

October 8, 2003

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C023
  • CO23, A8501023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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