Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT01155258
Phase
PHASE1
Status
Completed

Conditions

  • Extensive Stage Small Cell Lung Cancer
  • Hereditary Paraganglioma
  • Male Breast Cancer
  • Malignant Paraganglioma
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Metastatic Pheochromocytoma
  • Pancreatic Polypeptide Tumor
  • Recurrent Breast Cancer
  • Recurrent Cervical Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Recurrent Islet Cell Carcinoma
  • Recurrent Neuroendocrine Carcinoma of the Skin
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pheochromocytoma
  • Recurrent Prostate Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Small Cell Lung Cancer
  • Recurrent Uterine Sarcoma
  • Regional Gastrointestinal Carcinoid Tumor
  • Regional Pheochromocytoma
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage III Neuroendocrine Carcinoma of the Skin
  • Stage III Ovarian Epithelial Cancer
  • Stage III Ovarian Germ Cell Tumor
  • Stage III Prostate Cancer
  • Stage III Renal Cell Cancer
  • Stage III Uterine Sarcoma
  • Stage IIIA Breast Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Endometrial Carcinoma
  • Stage IV Neuroendocrine Carcinoma of the Skin
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Prostate Cancer
  • Stage IV Renal Cell Cancer
  • Stage IV Uterine Sarcoma
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Thyroid Gland Medullary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or metastatic solid tumors.

Key Dates

Start date
Jun 30, 2010
Status verified
Jun 2016
Primary completion
Jan 31, 2013
Completion
May 31, 2014

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

To determine the maximum tolerated dose of Temsirolimus and Vinorelbine [ Time Frame: 1 month up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

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By research site
USC/Norris Comprehensive Cancer Center· Los Angeles, CA

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