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CPG 7909 Injection in Melanoma

Primary Purpose

Carcinoma, Melanoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CPG 7909 Injection
dacarbazine
Chemotherapy
CPG 7909 Injection
CPG 7909 Injection
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Melanoma focused on measuring Immunotherapy, skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Experimental

    Arm Label

    CPG 7909 Injection plus chemotherapy

    Chemotherapy alone

    CPG 7909 Injection 10 mg

    CPG 7909 Injection 40 mg

    Arm Description

    CPG 7909 Injection plus DTIC

    dacarbazine

    Outcomes

    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.
    Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.

    Secondary Outcome Measures

    Phase III: Assess the overall response rate
    Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
    Determine the duration of response.
    Determine the time to progression
    Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
    Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone

    Full Information

    First Posted
    October 6, 2003
    Last Updated
    February 9, 2009
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00070642
    Brief Title
    CPG 7909 Injection in Melanoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Melanoma
    Keywords
    Immunotherapy, skin cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CPG 7909 Injection plus chemotherapy
    Arm Type
    Experimental
    Arm Description
    CPG 7909 Injection plus DTIC
    Arm Title
    Chemotherapy alone
    Arm Type
    Active Comparator
    Arm Description
    dacarbazine
    Arm Title
    CPG 7909 Injection 10 mg
    Arm Type
    Experimental
    Arm Title
    CPG 7909 Injection 40 mg
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    CPG 7909 Injection
    Other Intervention Name(s)
    ProMune, PF-3512676
    Intervention Description
    CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    dacarbazine
    Other Intervention Name(s)
    DTIC
    Intervention Description
    dacarbazine 850mg/m2 in three-week cycles until disease progression
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Other Intervention Name(s)
    DTIC
    Intervention Description
    Chemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    CPG 7909 Injection
    Other Intervention Name(s)
    ProMune, PF-03512676
    Intervention Description
    CPG 7909 Injection administered subcutaneously at a dose of 10 mg weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    CPG 7909 Injection
    Other Intervention Name(s)
    ProMune, PF-03512676
    Intervention Description
    CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
    Primary Outcome Measure Information:
    Title
    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
    Title
    Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
    Time Frame
    Indeterminate
    Secondary Outcome Measure Information:
    Title
    Phase III: Assess the overall response rate
    Time Frame
    indeterminate
    Title
    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
    Title
    Determine the duration of response.
    Time Frame
    indeterminate
    Title
    Determine the time to progression
    Time Frame
    indeterminate
    Title
    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
    Title
    Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
    Time Frame
    indeterminate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CO23&StudyName=CPG%207909%20Injection%20in%20Melanoma
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    CPG 7909 Injection in Melanoma

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