CPG 7909 Injection in Melanoma - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00070642

Purpose

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

Condition	Intervention	Phase
Carcinoma, Melanoma	Drug: CPG 7909 Injection Drug: dacarbazine Drug: Chemotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Dacarbazine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase III: Assess the overall response rate [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Determine the duration of response. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
Determine the time to progression [ Time Frame: indeterminate ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone [ Time Frame: indeterminate ] [ Designated as safety issue: Yes ]

Enrollment:	184
Study Start Date:	December 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CPG 7909 Injection plus chemotherapy: Experimental CPG 7909 Injection plus DTIC	Drug: CPG 7909 Injection CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly. Drug: dacarbazine dacarbazine 850mg/m2 in three-week cycles until disease progression
Chemotherapy alone: Active Comparator dacarbazine	Drug: Chemotherapy Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
CPG 7909 Injection 10 mg: Experimental	Drug: CPG 7909 Injection CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
CPG 7909 Injection 40 mg: Experimental	Drug: CPG 7909 Injection CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070642

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	C023, CO23, A8501023
Study First Received:	October 6, 2003
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00070642 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Immunotherapy, skin cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Carcinoma
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009