Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

NCT00014248 | Completed Phase 1

• 4 other identifiers: CDR0000068522DMS-0005ATP-DMS-0005NCI-G01-1923
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in patients with advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling loss of weight and loss of muscle mass in patients who have advanced solid tumors.

Conditions

Cachexia; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; cachexia

Interventions

adenosine triphosphate DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor that is not curable by conventional therapy * Brain metastases allowed if adequately controlled with radiotherapy PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 60-100% Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * SGOT and SGPT no greater than 3 times normal * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance greater than 60 mL/min * BUN no greater than 25 mg/dL Cardiovascular: * Adequate cardiovascular function * No congestive heart failure (New York Heart Association class III or IV heart disease) * No angina pectoris AND/OR * No significant arrhythmia * No myocardial infarction within the past 6 months * No clinically significant ischemic cardiac disease currently under treatment * No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block) Pulmonary: * Adequate pulmonary function * No clinical evidence of acute chronic obstructive pulmonary disease * FEV1 at least 50% predicted * Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air * No asthma OR * No evidence of more than 20% reversibility in FEV1 with albuterol therapy Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No history of severe adverse reaction to adenosine * No uncontrolled medical illness * No average daily pain scores of at least 5 on a simple Visual Analogue Self pain assessment (0-10) scale PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * At least 30 days since prior investigational therapy * At least 14 days since prior long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy * No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy * No concurrent maintenance anti-anginal drug therapy

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Conditions

Cachexia

Interventions

Adenosine Triphosphate

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Lionel D. Lewis, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: July 30, 2003
• Study Start: October 1, 2000
• Primary Completion: November 1, 2002
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

US (1)