Expired Study
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Birmingham, Alabama 35294


Purpose:

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 AG2037 in treating patients who have advanced, metastatic, or recurrent solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced, metastatic, or recurrent solid tumor. - Determine the safety and tolerance of this drug in these patients. - Assess the pharmacokinetics of this drug in these patients. - Document any antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor - Advanced, metastatic, or recurrent disease - No curative therapy exists - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome) - SGOT OR SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min Other: - No unstable or severe concurrent medical condition that would preclude study participation - No sociological or familial condition that would preclude study compliance - No psychological or addictive disorder that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 40% of bone marrow Surgery: - Not specified Other: - At least 2 weeks since prior blood transfusions - At least 4 weeks since prior investigational agent and recovered - No prior glycinamide ribonucleotide formyltransferase (GARFT) inhibitor - No concurrent extradietary folate supplements - No concurrent allopurinol - No other concurrent anticancer or investigational agents


Study is Available At:


Original ID:

CDR0000068699


NCT ID:

NCT00017524


Secondary ID:

UAB-0052


Study Acronym:


Brief Title:

AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors


Official Title:

A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Francisco Robert, MD, FACP
Study Chair
University of Alabama at Birmingham

Study Dates

Start Date:March 2001
Completion Date:November 2004
Completion Type:Actual
Verification Date:November 2012
Last Changed Date:December 12, 2013
First Received Date:June 6, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:pelitrexol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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