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CPG 7909 Injection in Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00070642
First Posted: October 8, 2003
Last Update Posted: February 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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 ]
  • Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II. [ Time Frame: Indeterminate ]

Secondary Outcome Measures:
  • Phase III: Assess the overall response rate [ Time Frame: 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 ]
  • Determine the duration of response. [ Time Frame: indeterminate ]
  • Determine the time to progression [ Time Frame: 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 ]
  • Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone [ Time Frame: indeterminate ]

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
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 Name: ProMune, PF-3512676
Drug: dacarbazine
dacarbazine 850mg/m2 in three-week cycles until disease progression
Other Name: DTIC
Active Comparator: Chemotherapy alone
dacarbazine
Drug: Chemotherapy

Chemotherapy in three-week cycles until disease progression:

dacarbazine 850mg/m2

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070642


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00070642     History of Changes
Other Study ID Numbers: C023
CO23, A8501023
First Submitted: October 6, 2003
First Posted: October 8, 2003
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Pfizer:
Immunotherapy, skin cancer

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas