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CPG 7909 Injection in Melanoma

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT00070642
Pfizer
Completed
CPG 7909 Injection in Melanoma

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Pfizer Clinical Trials Contact Center

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[email protected]

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CPG 7909 Injection in Melanoma
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
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Melanoma
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
December 2005
December 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00070642
C023
CO23, A8501023
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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