CPG 7909 Injection in Melanoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Melanoma

Treatments: Drug: CPG 7909 Injection; Drug: dacarbazine; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00070642

C023

CO23, A8501023

Details and patient eligibility

About

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

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 4 patient groups

CPG 7909 Injection plus chemotherapy

Experimental group

Description:

CPG 7909 Injection plus DTIC

Treatment:

Drug: CPG 7909 Injection

Drug: dacarbazine

Drug: CPG 7909 Injection

Drug: CPG 7909 Injection

Chemotherapy alone

Active Comparator group

Description:

dacarbazine

Treatment:

Drug: Chemotherapy

CPG 7909 Injection 10 mg

Experimental group

Treatment:

Drug: CPG 7909 Injection

Drug: CPG 7909 Injection

Drug: CPG 7909 Injection

CPG 7909 Injection 40 mg

Experimental group

Treatment:

Drug: CPG 7909 Injection

Drug: CPG 7909 Injection

Drug: CPG 7909 Injection