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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436735 |
RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir in treating patients with metastatic, refractory, or recurrent solid tumors.
Condition | Intervention | Phase |
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Colorectal Cancer Gastrointestinal Carcinoid Tumor Head and Neck Cancer Islet Cell Tumor Lung Cancer Metastatic Cancer Neuroendocrine Carcinoma of the Skin Ovarian Cancer Pheochromocytoma Sarcoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: midazolam hydrochloride Drug: nelfinavir mesylate Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis Other: mass spectrometry Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Nelfinavir (Viracept®) in Adults With Solid Tumors |
Estimated Enrollment: | 45 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive oral nelfinavir mesylate twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may continue to receive nelfinavir mesylate.
Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients receive oral midazolam hydrochloride on days -2 and 20 and then undergo blood collection on days -2 and 20 for midazolam pharmacokinetics to determine CYP3A4 activity. Nelfinavir mesylate pharmacokinetics are performed on day 1 of courses 1 and 2. Patients also undergo blood collection on days
1, 8, and 42 for biological marker laboratory studies, including vascular endothelial growth factor and basic fibroblast growth factor levels as measured by enzyme-linked immunosorbent assay and phospho-Akt, total Akt, cleaved Parp, Beclin 1, p-eIF2α, LC-3, and other signal transduction markers as measured by Western blot.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid malignancy for which there is no known curative therapy
Brain metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent CYP3A4 inhibitors, including any of the following:
Hydroxymethyl glutaryl co-enzyme A (HMG-CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Phillip Dennis, MD, PhD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000529905, NCI-07-C-0047, NCI-P6880 |
Study First Received: | February 15, 2007 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00436735 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent non-small cell lung cancer recurrent small cell lung cancer recurrent colon cancer recurrent rectal cancer recurrent adult soft tissue sarcoma recurrent uterine sarcoma ovarian sarcoma recurrent gastrointestinal carcinoid tumor pancreatic G-cell adenoma pancreatic G-cell carcinoma pancreatic alpha cell adenoma pancreatic alpha cell carcinoma pancreatic beta islet cell adenoma |
pancreatic beta islet cell carcinoma pancreatic delta cell adenoma pancreatic delta cell carcinoma recurrent islet cell carcinoma recurrent neuroendocrine carcinoma of the skin thyroid gland medullary carcinoma recurrent pheochromocytoma metastatic gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor liver metastases lung metastases stage IV follicular thyroid cancer stage IV papillary thyroid cancer recurrent thyroid cancer |
Thoracic Neoplasms Neurotransmitter Agents Carcinoma, Basosquamous Rectal Neoplasms Thyroid Cancer, Papillary Pancreatic Neoplasms Thyroid Cancer, Medullary Colonic Diseases Anesthetics Urogenital Neoplasms Rectal Diseases Neoplasms, Connective and Soft Tissue Thyroid Cancer, Follicular Lung Neoplasms Neoplasm Metastasis |
Neuroepithelioma Ovarian Cancer Neoplasms, Basal Cell Nelfinavir Endocrine Gland Neoplasms Carcinoid Syndrome HIV Protease Inhibitors Anti-HIV Agents Tranquilizing Agents Digestive System Neoplasms Carcinoma, Islet Cell Adjuvants, Immunologic Genital Neoplasms, Female Endocrine System Diseases Adenoma, Islet Cell |
Thoracic Neoplasms Anti-Infective Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Carcinoma, Basosquamous Pancreatic Neoplasms Physiological Effects of Drugs Colonic Diseases Anesthetics Urogenital Neoplasms Rectal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Site Pathologic Processes Lung Neoplasms |
Therapeutic Uses Neoplasm Metastasis Neoplasms, Basal Cell Nelfinavir Endocrine Gland Neoplasms HIV Protease Inhibitors Anti-HIV Agents Tranquilizing Agents Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carcinoma, Basal Cell Adenoma, Islet Cell Malignant Carcinoid Syndrome Protease Inhibitors |