Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Combretastatin; Fosbretabulin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer, including 1 of the following:

• Recurrent/regionally advanced disease no longer amenable to definitive curative surgery or radiotherapy

• Untreated metastatic disease NOTE: *If original/diagnostic tumor blocks are unavailable, tumor must be accessible for pretreatment core needle biopsy

• Must have relapsed or progressed during or after prior combined modality therapy (e.g., systemic chemotherapy and radiotherapy) for regionally advanced (but not metastatic) disease

• Measurable or evaluable disease

• Patent trachea and airway by screening direct and indirect laryngoscopy* NOTE: *For patients with bulky thyroid/neck masses and/or suspected airway obstruction

• No active brain metastases, as evidenced by any of the following:

• Symptomatic involvement

• Cerebral edema by CT scan or MRI

• Radiographic evidence of progression since definitive therapy

• Continued requirement for corticosteroids

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 75,000/mm^3

• Hemoglobin at least 8.5 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• ALT and AST no greater than 3.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• LVEF at least 50% by MUGA

• EKG normal

• No evidence of prior myocardial infarction (e.g., significant Q waves), QTc greater than 450 msec, or other clinically significant abnormalities

• No history of angina (even if controlled by medication)

• No congestive heart failure

• No uncontrolled atrial arrhythmias

• No clinically significant arrhythmias, including any of the following:

• Conduction abnormalities

• Nodal junctional arrhythmias and dysrhythmias

• Sinus bradycardia or tachycardia

• Supraventricular arrhythmias

• Atrial fibrillation or flutter

• Syncope or vasovagal episodes

• No significant heart wall abnormality or heart muscle damage by MUGA

• No uncontrolled hypertension (blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic regardless of medication)

• Patients with previous hypertension are allowed provided there is clinical documentation of controlled blood pressure for 2 months prior to study enrollment

• No symptomatic peripheral vascular disease

• No symptomatic cerebrovascular disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No grade 2 or greater preexisting motor or sensory peripheral neuropathy

• No uncontrolled hypokalemia or hypomagnesemia

• No concurrent serious infection

• No other nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by study therapy

• No psychiatric disorders or other conditions that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic therapy

• No concurrent immunotherapy

• No concurrent prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy, except any of the following:

• Gonadotropin-releasing hormone agonists for hormone-refractory prostate cancer

• Hormone replacement therapy

• Oral contraceptives

• Megestrol for anorexia/cachexia

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy with progressive disease beyond radiation ports

• No prior radiotherapy to more than 30% of the bone marrow

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• More than 4 weeks since prior major surgery

Other

• At least 6 weeks since other prior therapy associated with delayed toxicity

• No prior therapy for metastatic disease

• No concurrent medication(s) known to prolong the QTc interval, unless medication(s) can be held for at least 72 hours before, during, and for at least 6 hours after study drug administration

• No other concurrent investigational therapy

• No other concurrent antineoplastic or cytotoxic therapy