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

NCT01147029 | Terminated Phase 1

• 4 other identifiers: CDR0000675271CRUK-PH1-109EUDRACT-2006-002326-34CTA-21106-0222-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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 advanced solid tumors that have not responded to therapy.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

• Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0

Secondary Outcomes (5)

• Relationship between pharmacokinetics and toxicity and/or markers of efficacy

• Changes in microvascular function using DCE-MRI

• Plasma and tumor levels of angiogenic factors and apoptosis markers

• Response (stable disease, partial response, or complete response) as determined by RECIST criteria

• Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis

Interventions

angiogenesis inhibitor GSAO DRUG

laboratory biomarker analysis OTHER

pharmacological study OTHER

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (2)

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

MeSH Terms

Interventions

4-(N-(S-glutathionylacetyl)amino)phenylarsenoxide

Study Officials

• Gordon Jayson, MD

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: January 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

GB (2)