Sarcoma Clinical Trial
Official title:
A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease
Verified date | March 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis,
in childhood tumors. Once this advanced stage of disease is evident, survival is measured in
weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the
additive or synergistic effect of combining chemotherapy has been well established in adult
clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced
peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma.
This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion
with escalating doses of intraperitoneal cisplatin in the treatment of children with
refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal
cavity, the tumors must be able to be controlled.
Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal
metastases, this study will evaluate the safety of elevated temperature (40oC) with
intraperitoneal cisplatin chemotherapy.
Primary Objectives:
1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in
combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and
retroperitoneal solid tumors
2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II
trials
3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP
as a 90 minute abdominal perfusion (Optional)
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. Age greater than or equal to 3 and less than or equal to 18 years 2. Histologically proven diffuse peritoneal or retroperitoneal tumor from the following histologies: adenocarcinoma of the gastrointestinal tract, desmoplastic round cell tumor, late stage neuroblastoma, ovarian germ cell, sarcoma, adrenocorticocarcinoma, Wilms', rhabdomyosarcoma. (target groups: desmoplastic small round cell tumor (DSRCT), neuroblastoma, and recurrent tumors). If tumors are outside the abdominal cavity, the tumors must be controllable. 3. All patients must have refractory or recurrent tumors with no known curative treatment options. 4. Radiologic workup must demonstrate that the disease is confined to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled. 5. Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 mm thickness per tumor deposit 6. Patients must have minimum expected duration of survival of greater than 6 weeks 7. Patients must not have any systemic illness which precludes them from being an operative candidate. This includes but is not limited to sepsis, liver failure, pregnancy, lactating females. 8. Patients must have fully intact mental status and normal neurologic abilities. 9. Patients must have adequate renal function (serum creatinine </= 1.5 without history dialysis or renal failure) 10. Patients will be eligible if the white blood count (WBC) is > or =2,000/ul or Absolute neutrophil count (ANC) is > or =1,500, or platelets are > or = 100,000/mm^3 11. Patients will be eligible if serum total bilirubin and liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) are </= 2 times the upper limit of normal 12. Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment 13. If tumors are outside the abdominal cavity, the tumors must be controllable. Exclusion Criteria: 1. Patients who have failed previous continuous hyperthermic intraperitoneal perfusion with platinum therapy will be ineligible 2. Patients with tumors that are unable to be controlled outside the abdominal cavity will be ineligible 3. Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure 4. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin in children with peritoneal cancer | The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT). | Assessed during treatment and post surgery through hospital stay (estimated 5 days) followed one month later. | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04457258 -
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
|
Early Phase 1 | |
Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Recruiting |
NCT04535713 -
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
|
Phase 2 | |
Completed |
NCT03521531 -
Burden and Medical Care of Sarcoma in Germany
|
||
Completed |
NCT02496520 -
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
|
Phase 1/Phase 2 | |
Terminated |
NCT02054104 -
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
|
Phase 1/Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT04052334 -
Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
|
Phase 1 | |
Completed |
NCT01593748 -
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
Completed |
NCT01879085 -
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
Completed |
NCT01209598 -
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
|
Phase 2 | |
Completed |
NCT04553471 -
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
|
N/A | |
Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 |