CPG 7909 Injection in Melanoma

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NCT00070642

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed melanoma that is metastatic.

- Measurable disease according to the RECIST criteria.

- Karnofsky Performance Status of > 70.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Melanoma CarcinomaCPG 7909 Injection in Melanoma
NCT00070642
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE CPG 7909 Injection in Melanoma
Official Title  ICMJE 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
Brief Summary To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Melanoma
Intervention  ICMJE
  • 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
  • Drug: Chemotherapy

    Chemotherapy in three-week cycles until disease progression:

    dacarbazine 850mg/m2

    Other Name: DTIC
  • Drug: CPG 7909 Injection
    CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
    Other Name: ProMune, PF-03512676
  • Drug: CPG 7909 Injection
    CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
    Other Name: ProMune, PF-03512676
Study Arms  ICMJE
  • Experimental: CPG 7909 Injection plus chemotherapy
    CPG 7909 Injection plus DTIC
    Interventions:
    • Drug: CPG 7909 Injection
    • Drug: dacarbazine
  • Active Comparator: Chemotherapy alone
    dacarbazine
    Intervention: Drug: Chemotherapy
  • Experimental: CPG 7909 Injection 10 mg
    Intervention: Drug: CPG 7909 Injection
  • Experimental: CPG 7909 Injection 40 mg
    Intervention: Drug: CPG 7909 Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)		184
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		450
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00070642
Other Study ID Numbers  ICMJE C023
CO23, A8501023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP