GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Angiogenesis Inhibitors

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor

• Refractory to conventional treatment or for which no conventional therapy exists

• Disease assessable by DCE-MRI and should be of a size that can be adequately assessed by these techniques

• No known primary brain tumors or brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Life expectancy ≥ 12 weeks

• Hemoglobin ≥ 9.0 g/dL

• Platelet count ≥ 100 x 10^9/L

• Neutrophil count ≥ 1.5 x 10^9/L

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN

• Creatinine clearance ≥ 50 mL/min (uncorrected value)

• Serum potassium and magnesium normal

• No proteinuria > grade 1 either on 24-hour urine or on 2 consecutive dipsticks taken no less than 1 week apart

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy

• Not at high medical risk due to non-malignant systemic disease, including active uncontrolled infection

• No serologically positive hepatitis B, hepatitis C, or HIV

• No concurrent congestive heart failure or prior NYHA class III-IV cardiac disease

• None of the following medical conditions:

• Angina (stable or severe, even if well controlled on medication)

• Myocardial infarction in the past 2 months by ECG

• Congestive cardiac failure

• Arrhythmias, including any condition associated with QTc prolongation (e.g., Lange-Neilson syndrome or Romano Ward syndrome)

• Evidence of ischemia

• QTc > 480 msec

• Other clinically significant abnormalities

• No uncontrolled hypertension (defined as BP consistently greater than 160/100 mm Hg irrespective of medication)

• No other condition that, in the opinion of the investigator, would not make the patient a good candidate for this clinical trial

• No pacemakers

• No metal fragments in the eyes or shrapnel or bullet injuries

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from all prior treatments (except for alopecia or certain grade 1 toxicities which, in the opinion of the investigator and Cancer Research UK, should not exclude the patient)

• At least 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for nitrosoureas and mitomycin C)

• At least 1 week since prior and no concurrent shellfish

• At least 6 weeks since prior major surgery (including thoracic and/or abdominal surgery) and recovered

• Concurrent luteinizing-hormone releasing-hormone (LHRH) analogues allowed for patients with castration-refractory prostate cancer provided the prostate-specific antigen level is rising

• No prior heart or brain surgery

• No concurrent drug known to prolong the QTc interval

• No concurrent warfarin (1 mg for maintenance of a Hickman line is acceptable) or heparin (flushing of arterial lines, if necessary, is acceptable)

• No concurrent naproxen (other NSAIDs are acceptable)

• No concurrent prophylactic use of antiemetics during the first treatment

• Domperidone and lorazepam must not be used as antiemetics

• No other concurrent anticancer therapy or investigational drugs

• Concurrent bisphosphonates allowed