Endostatin in Treating Patients With Advanced Solid Tumors
A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors.
II. Determine the safety and tolerability of this regimen in these patients. III. Determine the extent, frequency, and duration of tumor response in these patients on this regimen.
IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients.
V. Determine the recommended phase II dose and schedule of this regimen.
OUTLINE: This is a dose escalation study.
Patients undergo a biopsy during prestudy and after the second course of treatment. Patients receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over 20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for 1 month.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven advanced solid tumor for which no standard curative therapy exists
- Must be amenable to biopsy At least 1 site of measurable disease outside of irradiated field
- No brain metastases by CT or MRI scan
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-1
- WBC greater than 3,000/mm3
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 10 g/dL
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT and AST less than 2.0 times ULN
- PT/PTT less than 1.5 times ULN
- Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent uncontrolled medical or psychiatric disorder
- No history of bleeding diathesis
PRIOR CONCURRENT THERAPY:
- No concurrent over the counter biologic agents (e.g., shark cartilage)
- At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin)
- No more than 3 prior chemotherapy regimens for metastatic or recurrent disease (ECOG 1)
- Prior adjuvant chemotherapy for nonmetastatic disease allowed
- Concurrent stable dose of hormone replacement therapy allowed
- At least 3 weeks since prior radiotherapy
- No concurrent radiotherapy
- At least 24 hours since minor surgery (e.g., central venous placement)
- At least 4 weeks since major surgery (e.g., laparotomy, thoracotomy, or craniotomy)
- At least 30 days since other prior investigational agents
- No concurrent herbal remedies
- No concurrent usage of products containing heparin
- No other concurrent anticancer therapy
- Concurrent multivitamins allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I
Patients undergo a biopsy during prestudy and after the second course of treatment.
Patients receive endostatin IV daily for 4 weeks.
Patients on dose level 1-6 receive endostatin over 20 minutes.
Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only.
Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02314
- MDA-ID-99201
- NCI-T99-0087
- CDR0000067471 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.