CPG 7909 Injection in Melanoma

NCT ID: NCT00070642

Last Updated: 2009-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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Conditions

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Carcinoma, Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPG 7909 Injection plus chemotherapy

CPG 7909 Injection plus DTIC

Group Type EXPERIMENTAL

CPG 7909 Injection

Intervention Type DRUG

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

dacarbazine

Intervention Type DRUG

dacarbazine 850mg/m2 in three-week cycles until disease progression

Chemotherapy alone

dacarbazine

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

Chemotherapy in three-week cycles until disease progression:

dacarbazine 850mg/m2

CPG 7909 Injection 10 mg

Group Type EXPERIMENTAL

CPG 7909 Injection

Intervention Type DRUG

CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.

CPG 7909 Injection 40 mg

Group Type EXPERIMENTAL

CPG 7909 Injection

Intervention Type DRUG

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Interventions

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CPG 7909 Injection

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Intervention Type DRUG

dacarbazine

dacarbazine 850mg/m2 in three-week cycles until disease progression

Intervention Type DRUG

Chemotherapy

Chemotherapy in three-week cycles until disease progression:

dacarbazine 850mg/m2

Intervention Type DRUG

CPG 7909 Injection

CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.

Intervention Type DRUG

CPG 7909 Injection

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Intervention Type DRUG

Other Intervention Names

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ProMune, PF-3512676 DTIC DTIC ProMune, PF-03512676 ProMune, PF-03512676

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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CO23, A8501023

Identifier Type: -

Identifier Source: secondary_id

C023

Identifier Type: -

Identifier Source: org_study_id

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