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NCT00070642 Clinical Trial

CPG 7909 Injection in Melanoma

Carcinoma, Melanoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00070642
Other study ID # C023
Secondary ID CO23, A8501023
Status Completed
Phase Phase 2
First received October 6, 2003
Last updated February 9, 2009
Start date December 2003
Est. completion date December 2005

Study information
Verified date February 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 184
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
• dacarbazine
dacarbazine 850mg/m2 in three-week cycles until disease progression
• Chemotherapy
Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
• CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
• CPG 7909 Injection
CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria. indeterminate No
Primary Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. Indeterminate No
Secondary Phase III: Assess the overall response rate indeterminate No
Secondary Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease. indeterminate No
Secondary Determine the duration of response. indeterminate No
Secondary Determine the time to progression indeterminate No
Secondary Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only). indeterminate No
Secondary Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone indeterminate Yes

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