Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Osteosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.

RAD001

Jin-Hee Ahn, MD, PhD

This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.

This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.

RAD001 in Advanced Sarcoma

A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas

Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment

Defined as the time from the initiation of everolimus to disease progression or death, whichever occurred first.

Defined from the initiation of everolimus to death of any cause.

Defined as the proportion of complete response and partial response per RECIST criteria.

Any adverse events occurred during the treatment with study drug.

Novartis

Asan Medical Center

Professor

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Leukemia

Lymphoma

Wilms Tumor

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Lymphosarcoma

Wilms' Tumor

Vincristine

Tubulin Modulators

Antimitotic Agents

Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days

Liposomal Vincristine

Cynthia E. Herzog, MD, BA

The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.

Before and during the treatment patients will have exams done. These may include blood tests, urine tests, bone marrow tests, tests of the central nervous system, x-rays, or MRI/CT test. These are needed to measure the patient's clinical condition and progress. A physical exam and blood tests (about 2 teaspoons) will be repeated at least one time weekly.

Since Liposomal Vincristine may prevent the body from making and/or keeping new blood cells, prior to treatment patients will also have a Human Immunodeficiency Virus (AIDS virus) test, a blood test to detect the presence of antibodies to the AIDS virus. A separate informed consent will be given to be signed, in order to obtain permission for this test. Female patients may also be required to have a urine pregnancy test before treatment may begin, as it is not known how the drug may affect the unborn child.

Patients will receive liposomal vincristine through a central venous catheter (a plastic tube usually inserted under the collar bone) over one hour, once every 14 days, + 2 days. Patient's will also be given the drug docusate by the day liposomal vincristine is started. This is done to try to prevent constipation as a side effect.

All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months. Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor. Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment, and then every 8 weeks.

This is an investigational study. The FDA has authorized the use of the study drug in research. Up to 60 patients will take part in this study. Up to 30 patients will be enrolled at UTMDACC.

Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

Response defined as Complete Response or Partial Response.

Inex Pharmaceuticals

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RAD001 in Advanced Sarcoma	NCT01830153	Soft Tissue Sar... Bone Sarcomas	RAD001	17 Years -	Asan Medical Center
Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies	NCT00038207	Soft Tissue Sar... Lymphoma Leukemia Wilms' Tumor Osteosarcoma	Liposomal Vincr...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for bone sarcomas