Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AI052413-01A1 | U.S. NIH Grant/Contract | View source | |
| BMT135 | Other Identifier | OnCore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease
To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation [aka peripheral blood stem cell (PBSC)].
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Autologous HCT | Experimental | Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug |
|
| |
| Vinorelbine |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity | Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Toxicity (BCNU Pneumonitis) | Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU). | 2 years |
| Overall Survival (OS) |
Not provided
Inclusion Criteria:
Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
Age < 70 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
Phase 1 study component only: 1 or more of the following adverse risk factors
Phase 2 study component only: No risk factor criteria
Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended
Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control
Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration)
Serum creatinine < 2 x the institutional ULN (within 28 days prior to registration)
Measured or estimated creatinine clearance > 60 cc/min by the following formula (within 28 days prior to registration):
Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration)
Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult
Corrected diffusion capacity > 55%
Written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
Positive HIV antibody test (must be conducted within 42 days of registration)
No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy
Pregnant
Breast-feeding
Requiring therapy for:
Over age 50 and has received chest irradiation or a total of 300 mg/m^2 of doxorubicin
History of cardiac disease and the ejection fraction is < 40% (radionuclide ejection fraction must be within 42 days of registration)
Known allergy to etoposide
History of Grade 3 hemorrhagic cystitis with cyclophosphamide
History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use
No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sally Arai, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20197102 | Background | Arai S, Letsinger R, Wong RM, Johnston LJ, Laport GG, Lowsky R, Miklos DB, Shizuru JA, Weng WK, Lavori PW, Blume KG, Negrin RS, Horning SJ. Phase I/II trial of GN-BVC, a gemcitabine and vinorelbine-containing conditioning regimen for autologous hematopoietic cell transplantation in recurrent and refractory hodgkin lymphoma. Biol Blood Marrow Transplant. 2010 Aug;16(8):1145-54. doi: 10.1016/j.bbmt.2010.02.022. Epub 2010 Mar 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue | Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)]. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I Dose Escalation |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Carmustine | Drug |
|
|
| Etoposide | Drug |
|
|
| Cyclophosphamide | Drug |
|
|
| Autologous HCT | Procedure |
|
|
Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
| 2 years |
| Relapse Post-transplant | Reports the percentage of participants that experienced relapse post-transplant. | 2 years |
| Survival Measures | Reports the survival measures:
EFS and OS were estimated by Kaplan-Meier method Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 2 years |
| 1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue |
Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)]. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 Dose Expansion |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + High-dose Chemotherapy + PBSC Rescue | Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)]. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity | Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events. | 7 patients received 1 of 2 dose levels during the Phase 1 dose-escalation component of the study | Posted | Number | participants | 6 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Pulmonary Toxicity (BCNU Pneumonitis) | Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU). | Patients who completed the study regardless of gemcitabine dose, and had all data points collected. | Posted | Number | participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Reports the percentage of participants surviving 6 months after PBSC infusion (transplant). | All participants | Posted | Number | percentage of participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Relapse Post-transplant | Reports the percentage of participants that experienced relapse post-transplant. | All participants | Posted | Number | percentage of participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Survival Measures | Reports the survival measures:
EFS and OS were estimated by Kaplan-Meier method Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Lists the results as included in the publication, which included 92 participants who received the MTD treatment; completed the study; and had all data points collected | Posted | Number | 95% Confidence Interval | percentage of patients | 2 years |
|
|
2 years
All events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine + High-dose Chemotherapy + PBSC Rescue | Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)]. | 31 | 146 | 17 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment | persistent fevers included |
| |
| Constipation | Gastrointestinal disorders | Systematic Assessment | Includes severe |
| |
| Cardiac ischemia | Cardiac disorders | Systematic Assessment | myocardial infraction |
| |
| Ventricular arythmia | Cardiac disorders | Systematic Assessment | includes Left ventricular systolic dysfunction |
| |
| osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Failed to engraft | General disorders | Systematic Assessment |
| ||
| Veno-occlusive disease | Cardiac disorders | Systematic Assessment |
| ||
| Progressive liver failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Allergic reaction | General disorders | Systematic Assessment |
| ||
| Relapse | Infections and infestations | Systematic Assessment |
| ||
| Intubated | General disorders | Systematic Assessment |
| ||
| Multisystem organ failure | General disorders | Systematic Assessment |
| ||
| Neutropenia | Infections and infestations | Systematic Assessment |
| ||
| Discharge | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Respiratory distress | Cardiac disorders | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment | including severe |
| |
| Metabolic abnormalities | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Tachypenic | Cardiac disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Friable fascial plane | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Candida albicans | Infections and infestations | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| diffusing capacity of the lung for carbon monoxide (DLCO) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Elevated troponin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenic fever | Infections and infestations | Systematic Assessment |
| ||
| Nodular infiltrates | Blood and lymphatic system disorders | Systematic Assessment | Located in right and left lower lobes |
| |
| Parpneumonic effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sally Arai | Stanford University | 650-723-0822 | sarai1@stanford.edu |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|