CPG 7909 Injection in Melanoma

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00070642
First received: October 6, 2003
Last updated: February 9, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Pfizer:
Immunotherapy, skin cancer

Additional relevant MeSH terms:
Carcinoma
Melanoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014