Study of EC0225 for the Treatment of Refractory or Metastatic Tumors

NCT ID: NCT00441870

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-11-30

Brief Summary

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Detailed Description

This is a Phase 1, dose escalation study of EC0225 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0225; however, lab research (research in test tubes or animals) using EC0225 has shown activity against tumors in animals. This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus. The efficacy of treatment will also be measured.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate)

Dose escalation from a starting dose of 0.38mg IV bolus Monday Wednesday and Friday Weeks 1 and 3 of a 4 Week Cycle to the Maximum Tolerated Dose (MTD)

Intervention Type: DRUG

99mTC-EC20 (Folic acid-technetium 99m conjugate)

20-25 mCi 99m Tc-EC20 administered IV 1-2 hours prior to imaging

Intervention Type: DRUG

Other Intervention Names

Folic acid desacetylvinblastine hydrazide conjugate; Folic acid-technetium 99m conjugate; FolateScan

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Histological or cytological diagnosis of neoplasm
• No effective standard therapeutic options
• ECOG performance status of 0-2
• ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
• Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225)
• Adequate bone marrow reserve, renal and hepatic function

Exclusion Criteria

• Concurrent malignancies
• Women who are pregnant or lactating
• Evidence of symptomatic brain metastases
• Receiving concomitant anticancer therapy (excluding supportive care)
• Requires palliative radiotherapy at time of study entry
• Unable to tolerate conditions for radionuclide imaging
• Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endocyte

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A. Messmann, MD, MHS, MSc

Role: STUDY_DIRECTOR

Endocyte

Locations

Greenebaum Cancer Center - University of Maryland Medicine

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

EC-0225-01

Identifier Type: -

Identifier Source: org_study_id