Recurrent Rectal Cancer Clinical Trial
Official title:
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2
(deleted CH2 region) in patients with colorectal cancer.
II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and
conjugate stability of this drug in these patients.
III. Determine the ability of this drug to localize to tumor sites in these patients.
IV. Determine the immune response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1
and a therapy dose over 30 minutes on day 8.
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody
CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5
patients experience reversible grade 4 hematologic toxicity.
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease
progression.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
| Active, not recruiting |
NCT00826540 -
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT00025337 -
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
|
Phase 3 | |
| Recruiting |
NCT04642924 -
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Completed |
NCT01217450 -
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
| Terminated |
NCT01285102 -
Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer
|
Phase 1 | |
| Terminated |
NCT01238965 -
Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy
|
Phase 1 | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
| Completed |
NCT00551421 -
Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00407654 -
VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
Phase 2 | |
| Terminated |
NCT00052585 -
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05076305 -
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
|
||
| Completed |
NCT01740648 -
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
|
Phase 1 | |
| Terminated |
NCT00397878 -
AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer
|
Phase 2 | |
| Completed |
NCT00100841 -
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 |