Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors

NCT00098514 | Completed Phase 1 DMC FDA Drug

• 6 other identifiers: 03-183P30CA006516CDR0000400150NCI-6400DFCI-IRB-03183HANABIO-DFCI-02000
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (7)

Dose Level 1a

EXPERIMENTAL

10 mg/m2 dose of PT523 administered day 1 of a 28-day cycle as a 5 minute IV infusion (IV bolus)

Drug: talotrexin ammonium

Dose Level 1b

EXPERIMENTAL

5 mg/m2 dose of PT523 administered days 1 and 8 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Dose Level 1c

EXPERIMENTAL

3.33 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Dose Level 2

EXPERIMENTAL

5 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Dose Level 3

EXPERIMENTAL

7.5 mg/m2 dose (or 6.7 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Dose Level 4

EXPERIMENTAL

11.25 mg/m2 dose (or 9 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Dose Level 5

EXPERIMENTAL

17 mg/m2 dose (or 12 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion

Drug: talotrexin ammonium

Interventions

talotrexin ammonium DRUG

Dose Level 1a; Dose Level 1b; Dose Level 1c; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of malignant solid tumor * Metastatic or inoperable disease * No known curative or survival-prolonging palliative therapy exists OR failed these prior therapies * No leukemia * No primary CNS tumor * No third-space fluid collection (i.e., pleural effusion, ascites) * Clinically insignificant small pleural or peritoneal effusions identified by CT scan, MRI, or other diagnostic test allowed * No active\* brain metastases, including the following: * Evidence of cerebral edema by CT scan or MRI * Progression since prior imaging study * Requirement for steroids * Clinical symptoms of/from brain metastases NOTE: \*Treated and/or stable brain metastasis allowed provided patient is asymptomatic PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * RBC folate ≥ lower limit of normal Hepatic * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal Renal * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled serious medical or psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bone marrow transplantation Chemotherapy * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * See Disease Characteristics Radiotherapy * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * Recovered from prior therapy * More than 3 weeks since prior antifolate therapy

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Joseph Paul Eder, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Early Drug Development Center

Model Details: There were 7 potential PT523 single agent dose levels to be evaluated in this phase I study

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: December 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2011
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

US (1)