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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 1996-195 |
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The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
This is a phase II trial designed to provide a transplant option for patients with rare poor-prognosis cancers. The protocol is only open to patients with metastatic or relapsed cancers for whom the probability of remaining free of progressive disease for one year after being brought into remission is < 25%. Patients eligible for this study have been diagnosed with a form of cancer that leads to death more than 75% of the time when treated with standard therapy doses of chemotherapy and/ or radiation therapy. Under this treatment intensification protocol the expectation is that the one year progression-free survival for this group of patients will rise to 40%. Patients eligible for this protocol will be followed for one year post-transplant. Patients alive and free of progressive disease at the end of this period will be considered successes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloablative Chemotherapy with Stem Cell Rescue | Experimental | Myeloablative Chemotherapy, followed by stem cell rescue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myeloablative Chemotherapy | Procedure | High dose chemotherapy (carboplatin and thiotepa) transplant rescue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Progression Free Survival at 1 Year | The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse. | 1 year post transplant |
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Inclusion Criteria:
Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:
Disease status: Within 3 weeks of initiation of this protocol, patients must:
Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:
Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).
Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program
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| Name | Affiliation | Role |
|---|---|---|
| John E. Levine, MS MD | The Univeristy of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Myeloablative Chemotherapy With Stem Cell Rescue | Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue Stem Cell Rescue: autologous stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Stem Cell Rescue | Procedure | autologous stem cell transplantation |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Myeloablative Chemotherapy With Stem Cell Rescue | Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue Stem Cell Rescue: autologous stem cell transplantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Participants With Progression Free Survival at 1 Year | The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse. | Posted | Number | percentage of participants | 1 year post transplant |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Myeloablative Chemotherapy With Stem Cell Rescue | Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue Stem Cell Rescue: autologous stem cell transplantation | 19 | 25 | 12 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucocitis | Gastrointestinal disorders |
| |||
| Infection | Infections and infestations |
| |||
| Thrombocytopenia | Investigations |
| |||
| Death | General disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Fever | General disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Tachypnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Febrile Transfusion Reaction | Immune system disorders |
| |||
| Dermatitis | Skin and subcutaneous tissue disorders |
| |||
| Neutropenic Fever | Blood and lymphatic system disorders |
| |||
| Graft Failure | General disorders |
| |||
| Hypertension | Cardiac disorders |
| |||
| Disease Relapse | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Renal Failure | Renal and urinary disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypcalcemia | Metabolism and nutrition disorders |
| |||
| Enterocolitis | Gastrointestinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Total Bilirubin | Investigations |
| |||
| Hypomagnesemia | Metabolism and nutrition disorders |
| |||
| Hypernatremia | Metabolism and nutrition disorders |
| |||
| ALK | Investigations |
| |||
| AST | Investigations |
| |||
| ALT | Investigations |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Hypoalbuminemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Esophagitis | Gastrointestinal disorders |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Mucocitis | Gastrointestinal disorders |
| |||
| Hearing Loss | Ear and labyrinth disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John E. Levine, MD | University of Michigan Cancer Center | 734-936-8456 | jelevine@umich.edu |
| ID | Term |
|---|---|
| D009396 | Wilms Tumor |
| D005354 | Fibrosarcoma |
| D002277 | Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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