Clinical trial · Interventional

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

NCT00070642CI-TRIAL-00002037completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Melanoma	Carcinoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Chemotherapy	Drug	Chemotherapy	ALIAS
CPG 7909 Injection	Drug	—	UNRESOLVED
dacarbazine	Drug	Dacarbazine	ALIAS

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
CPG 7909 Injection plus chemotherapy
description
CPG 7909 Injection plus DTIC
interventionNames
1. Drug: CPG 7909 Injection
2. Drug: dacarbazine
type
ACTIVE_COMPARATOR
label
Chemotherapy alone
description
dacarbazine
interventionNames
1. Drug: Chemotherapy
type
EXPERIMENTAL
label
CPG 7909 Injection 10 mg
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.