Status:
TERMINATED
GSAO in Treating Patients With Advanced Solid Tumors That Have Not Responded to Therapy
Lead Sponsor:
Cancer Research UK
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 advan...
Detailed Description
OBJECTIVES: Primary * To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors. * To assess the safety ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01147029
Start Date
January 1 2008
End Date
April 1 2012
Last Update
May 1 2012
Active Locations (2)
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1
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
2
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ