Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00003703 | Completed Phase 1

• 5 other identifiers: CDR0000066810JGH-CR97097CR-97-0917CR9809NINCI-T98-0015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

SarCNU DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid malignancy for which no curative or life-extending therapy exists No prior or concurrent CNS metastases Primary CNS tumors allowed if on a stable dose of steroids at least 2 weeks before study entry No myelodysplastic syndrome PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 120,000/mm3 Hemoglobin greater than 8 g/dL Hepatic: Bilirubin normal AST and ALT less than 2.5 times upper limit of normal Renal: Creatinine less then 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No uncontrolled cardiac disease No uncontrolled hypertension Pulmonary: DLCO and vital capacity greater than 80% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative Oral intake at least 1,200 calories per day No recent weight loss of more than 10% actual body weight No serious concurrent illness No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent cytostatic or cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy No concurrent dexamethasone Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: At least 3 weeks since prior major surgery

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

Sponsors & Collaborators

• Jewish General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• Panasci L, Stinson SF, Melnychuk D, Sandor V, Miller WH Jr, Batist G, Patenaude F, Bangash N, Panarello L, Alaoui-Jamali M, Sausville E. SarCNU, a nitrosourea analog on a day 1, 5, and 9 oral schedule: a phase I and pharmacokinetic study in patients with advanced solid tumors. J Clin Oncol. 2003 Jan 15;21(2):232-40. doi: 10.1200/JCO.2003.03.047.

  PMID: 12525514 RESULT

MeSH Terms

Interventions

2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Study Officials

• Lawrence C. Panasci, MD

  Jewish General Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 15, 2004
• Study Start: January 1, 1999
• Study Completion: March 1, 2004
• Last Updated: March 26, 2013

Record last verified: 2002-09

Locations

CA (1)