NCT00002915

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of penclomedine in treating patients who have advanced solid tumors.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

First QC Date

November 1, 1999

Last Update Submit

August 5, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

penclomedineDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically documented solid tumor that is refractory to conventional therapy or for which no conventional treatment exists No primary or secondary brain tumor No CNS disease or treatment-related CNS dysfunction No bone metastases involving 4 or more sites PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,500 Platelet count greater than 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection No history of egg protein allergy No prior gastric or small intestine resection or clinical evidence of malabsorption No history of medical, neurologic, or psychiatric disorder No concomitant medical problem unrelated to the malignancy that precludes study compliance or increases treatment risk No pregnant women Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No more than 4 courses of combination chemotherapy that included an alkylating agent, cisplatin, or carboplatin (applies once grade 1 or worse myelosuppression is reported on this study) No prior mitomycin or nitrosoureas At least 28 days since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to wide ports involving pelvis or 20% of bone marrow At least 28 days since large-field radiotherapy No concurrent radiotherapy Surgery: At least 14 days since major surgery Other: No bone marrow transplantation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

penclomedine

Study Officials

  • Ross C. Donehower, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

December 1, 1996

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(1)