Renal Cell Carcinoma Clinical Trial
— Aflac ST0901Official title:
Sirolimus in Combination With Metronomic Therapy in Children With Recurrent and Refractory Solid Tumors: A Phase I Study
Verified date | May 2020 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The best treatment for recurrent cancers or those that do not respond to therapies is not
known. Typically, patients with these cancers receive a combination of cancer drugs
(chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but
may not offer a long-term cure.
This study proposes using a drug called Sirolimus in combination with common chemotherapy
drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found
to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous
studies and, therefore, has the potential to increase the effectiveness of the chemotherapy
drugs when given together.
This study wil investigate the highest dose of Sirolimus that can be given orally with other
oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose
will be increased in the next 2 subjects as long as there were no major reactions in the
previous groups. This study will also seek to learn more about the side effects of sirolimus
when used in this combination and what effects the drug has on the white cells and the immune
system. Successful use of this drug will impact the cancer population greatly by providing an
increased chance of survival to those with resistant or recurrent cancers.
Status | Completed |
Enrollment | 18 |
Est. completion date | August 9, 2017 |
Est. primary completion date | August 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility |
Inclusion Criteria: - must be <=30 years of age at time of study enrollment - histologic verification of malignancy at original diagnosis or relapsis except in patients with intrinsic brain stem tumors, optic pathway gliomas or patients wtih pineal tumors and evaluations of serum or CSF alpha-fetoprotein or beta-HCG - measurable or evaluable disease - disease state must be one for which there is no known curative therapy - Performance level >=50% - Patients must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy - no evidence of acute graft vs. host disease and >=3 months since transplant - organ function as defined in eligibility section of protocol Exclusion Criteria: - patients cannot be pregnant or breast-feeding - patients must agree to use of an effective contraceptive method - no growth factors that support platelet or white cell number or function for at least 7 days prior to enrollment - patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible - patients receiving any other investigational drugs - patients receiving any other anti-cancer drugs - patients who have an uncontrolled infection |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Children's Healthcare of Atlanta |
United States,
Qayed M, Cash T, Tighiouart M, MacDonald TJ, Goldsmith KC, Tanos R, Kean L, Watkins B, Suessmuth Y, Wetmore C, Katzenstein HM. A phase I study of sirolimus in combination with metronomic therapy (CHOAnome) in children with recurrent or refractory solid an — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) | estimate the maximum tolerated dose (MTD) and recommended Phase II dose of sirolimus administered orally once daily for 42 days in combination with metronomic chemotherapy in children with recurrent or refractory solid tumors. | 2 years after treatment starts | |
Secondary | define and describe toxicities of sirolimus | To define and describe the toxicities of sirolimus administered in combination with metronomic chemotherapy administered according to this schedule. | 2 years post treatment | |
Secondary | anti-tumor activity of sirolimus | To assess the antitumor activity of sirolimus administered in combination with metronomic chemotherapy to children with recurrent and refractory solid tumors within the confines of a Phase I study. | 2 years post treatment | |
Secondary | evaluate correlation of p70S6 kinase activity | To evaluate the correlation of p70S6 kinase activity inhibition with tumor response. | 2 years post treatment | |
Secondary | evaluate risk of infection | To evaluate the effect of this combination therapy on lymphocyte subsets and memory T-cells, and to correlate that with risk of infection. | 2 years post treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT03052504 -
Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy
|