Trials Sponsors Conditions Drugs Pricing

Conditions

Brain and Central Nervous System Tumors Prostate Cancer

Keywords

adult glioblastomarecurrent prostate cancerrecurrent adult brain tumorstage IV prostate canceradult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

Overall Objective Response
Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)
2 years

Study Arms (1)

Everolimus (RAD-001) and Gefitinib

EXPERIMENTAL

•Phase I: Patients receive oral everolimus on day 1 and oral gefitinib once daily on days 8-21. Beginning on day 22, patients receive oral everolimus once weekly and oral gefitinib once daily. Treatment with the combination continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of everolimus 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. •Phase II (prostate cancer patients only) (closed to accrual as of 10/19/2006): Patients receive oral everolimus (at the MTD determined in phase I) once weekly and oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: everolimusDrug: gefitinib

Interventions

everolimusDrug

Everolimus (RAD-001) and Gefitinib

gefitinibDrug

Everolimus (RAD-001) and Gefitinib

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Glioblastoma multiforme (GBM) (phase I only) * Progressive disease despite standard therapy * Progressive disease based on 1 of the following: * New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI * New or prior lesions that have increased in size by physical examination * Patients who had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true disease progression (rather than radiation necrosis) by positron-emission tomography scan, thallium scanning, magnetic resonance spectroscopy, or surgical documentation * Castrate metastatic prostate cancer (closed to accrual as of 10/19/2006) (phase I and II) * Progressive disease despite standard therapy AND castrate levels \< 50 ng/dL of testosterone * Progressive disease based on 1 or more of the following: * A minimum of 3 rising levels of prostate-specific antigen (PSA) that are obtained 1 or more weeks apart OR 2 rising PSA values obtained more than 1 month apart with at least a 25% increase over the range of values * New or progressive (25% bidimensional increase) soft tissue masses on CT scan or MRI * New metastatic lesions * Patients on an antiandrogen as part of initial therapy must show disease progression after discontinuation of the antiandrogen * Patients who have not undergone surgical orchiectomy must continue with medical therapy (e.g., gonadotropin-releasing hormone analogs) to maintain castrate levels of serum testosterone * No brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * ALT and AST ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine within 1.5 times ULN (\< 1.95 mg/dL at MSKCC) Cardiovascular * No significant cardiovascular disease * No congestive heart failure * No New York Heart Association class III or IV cardiac disease * No active angina pectoris * No myocardial infarction within the past 6 months Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No serious medical illness * No severe infection * No severe malnutrition * No other active malignancy except non-melanoma skin cancer * Patients are not considered to have an active malignancy if they have completed prior therapy and currently have a \< 30% risk for relapse PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biological therapy * No concurrent immunotherapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * Prior recent resection of recurrent or progressive GBM allowed provided patient has recovered * More than 4 weeks since prior major surgery Other * Recovered from all prior therapy * More than 4 weeks since prior investigational anticancer drugs * No concurrent anticonvulsant that interacts with CYP3A4 (e.g., phenytoin, carbamazepine, or phenobarbital) * No other concurrent cytotoxic therapy * No other concurrent investigational or commercial agents or therapies for the malignancy

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

MeSH Terms

Conditions

Central Nervous System NeoplasmsProstatic NeoplasmsGlioblastomaBrain NeoplasmsGliosarcoma

Interventions

EverolimusGefitinib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, Male

Results Point of Contact

Title: Dr. Howard Scher
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Howard I. Scher, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR
Neal Rosen, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR
Lauren E. Abrey, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

61 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Everolimus (RAD-001) and Gefitinib

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Everolimus (RAD-001) and Gefitinib

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations