Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Eye Diseases

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Diseases and Abnormalities at or Before Birth

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Renal Cell

Liver Neoplasms

Glioma

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Wilms Tumor

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Astrocytoma

Ependymoma

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Desmoplastic Small Round Cell Tumor

Hepatoblastoma

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Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Ovarian Cancer

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Renal Cell Carcinoma

Soft Tissue Sarcoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Brain Tumor, Adult

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Neuroepithelioma

Malignant Germ Cell Tumor

Extragonadal Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Melphalan

Lenograstim

Busulfan

Liver Extracts

Thiotepa

Amifostine

Adjuvants, Immunologic

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Protective Agents

Radiation-Protective Agents

Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.

amifostine trihydrate

Patients receive oral busulfan every 6 hours on days -8 to -6.

busulfan

All patients receive filgrastim (G-CSF) IV for 1 week.

filgrastim

melphalan intravenous (IV) over 30 minutes on days -5 and -4

melphalan

thiotepa intravenous (IV) over 2 hours on days -3 and -2.

thiotepa

peripheral blood stem cell transplantation (PBSC)

John P. Perentesis, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.

OBJECTIVES:

* Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors.
* Determine response or time to disease progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to age (1 to 18 vs 19 to 45 years).

All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration, patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy.

Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. PBSC are reinfused on day 0.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose 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 are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC transplantation.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors

Masonic Cancer Center, University of Minnesota

John Perentesis, MD

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Carcinoma

Endometrial Neoplasms

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Stomach Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Stomach Cancer

SGN-ALPV

Suzanne McGoldrick, MD

This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.

A Study of SGN-ALPV in Advanced Solid Tumors

A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

The proportion of participants with an objective response (OR) per investigator. A participant is determined to have an OR if, based on RECIST v1.1, the subject achieves a complete response (CR) or a partial response (PR) after initiation of treatment and at or prior to the end of treatment (EOT) disease assessment.

The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause.

The time from start of study treatment to first documentation of disease progression or death due to any cause

The time from start of study treatment to death due to any cause

The proportion of participants with ovarian cancer who have at least a 50% reduction in CA-125 value from baseline according to GCIG CA-125 criteria

The proportion of participants with ovarian cancer whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria

Seagen Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
A Study of SGN-ALPV in Advanced Solid Tumors	NCT05229900	Ovarian Neoplas... Endometrial Neo... Carcinoma, Non-... Stomach Neoplas... Gastroesophagea... Uterine Cervica... Testicular Neop...	SGN-ALPV	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for malignant ovarian germ cell tumor