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Completed

NCT Number: NCT00070642

CPG 7909 Injection in Melanoma

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

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Key information

Conditions

Carcinoma, Melanoma Carcinoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPG 7909 Injection

Drug

CPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.

Other names: ProMune, PF-3512676

Dacarbazine

Drug

dacarbazine 850mg/m2 in three-week cycles until disease progression

Other names: DTIC

Chemotherapy

Drug

Chemotherapy in three-week cycles until disease progression:

dacarbazine 850mg/m2

Other names: DTIC

Primary outcomes

  1. 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

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

    Time frame: Indeterminate

Secondary outcomes

  1. Phase III: Assess the overall response rate

    Time frame: indeterminate

  2. 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

  3. Determine the duration of response.

    Time frame: indeterminate

  4. Determine the time to progression

    Time frame: indeterminate

  5. 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

  6. Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone

    Time frame: indeterminate

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 8, 2003
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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