Clinical trial NCT00004229: Endostatin in Treating Patients With Advanced Solid Tumors
Official title: A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Roy S. Herbst, MD, PhD
role: STUDY_CHAIR
References: