Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Leukemia

Lymphoma, Non-Hodgkin

Hematologic Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Etoposide

Cyclophosphamide

Mycophenolic Acid

Sirolimus

Etoposide phosphate

Busulfan

Carmustine

Immunosuppressive Agents

Temsirolimus

MTOR Inhibitors

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Clotrimazole

Miconazole

Antifungal Agents

For subjects 18-60 years old with lymphoma: (BCNU+ VP-16 +CY) BCNU 15 mg / kg (maximum dose 550 mg/m² actual body weight) on day -6. VP 60 mg / kg on day 4 and CY 100 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis

For subjects 18-50 years old with AML, ALL or CML: (VP-16 +CY+ FBI) Patients aged 18-50 years with AML, ALL or CML: FTBI 1320 cGy delivered in 11 120 cGy fractions over 4 days on days -8 through -5. VP 60 mg / kg on day -4 and CY 60 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis

For subjects 51-60 years with MDS, AML or ALL or 18-60 with MDS, secondary AML pr non-CML myeloproliferative disease: (BU+ VP-16 +CY) BU 1 mg/kg every 6 hours X 14 doses on days -9 through -6 with target concentration at steady state of X 800 ng / ml based on first dose pharmacokinetics. VP 60 mg / kg on day -5 and CY 45 mg / kg per day -2 days on day -3 and day -2. Followed by Sirolimus and MMF as prophylaxis

Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults

Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion

BCNU

VP-16

For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg

1320 cGy delivered in 11 120 cGy fractions over 4 day

FTBI

Laura Johnston

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.

Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

Stanford University

Associate Professor of Medicine

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Fludarabine

Fludarabine phosphate

Immunomodulating Agents

FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master human induced pluripotent stem cell (iPSC) line with the following engineered elements: a) deletion of the gene encoding CD38 (i.e., CD38 knockout) and expression of the MICA and MICB (MICA/B) chimeric antigen receptor (CAR); b) high-affinity, non-cleavable CD16 receptor; and c) interleukin (IL)-15/IL-15 receptor alpha fusion protein. Participants will receive doses on Day 1, Day 4 and day 8.

FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.

FT536

Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.

CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.

Melissa Geller, MD

This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer.

A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT)

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

National Cancer Institute (NCI)

Masonic Cancer Center, University of Minnesota

Digestive System Diseases

Colorectal Neoplasms

Colonic Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Digestive System Neoplasms

Rectal Diseases

Herbal and Botanical

Molgramostim

Sargramostim

Vaccines

Guadecitabine

Cola

During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2, the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 Granulocyte macrophage-colony stimulating factor (GM-CSF) secreting cells, and SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.

During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2, Cyclophosphamide (CY) is administered on Day 8 at 200 mg/m2, and the colon cancer tumor vaccine (GVAX) is administered on Day 9 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.

During each of the four cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 and the colon cancer tumor vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.

During each of the four cycles, SGI-110 is administered on Days 1-5 at 60 mg/m2. Each cycle is 28 days. Enrollment will begin first in Cohort 1 and 2. If a response to the treatment is seen in Cohorts 1 and 2, enrollment in Cohort 3 and 4 will begin.

CY is administered intravenously at 200 mg/m2

GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells

GVAX

SGI-110 is administered subcutaneously at 60 mg/m2

SGI-110

Nilofer Azad, MD

This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.

SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy

Astex Therapeutics, Ltd

Susan Cohan Colon Cancer Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Agents

Nivolumab

Pancrelipase

Pancreatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6

CRS-207

1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6

3 mg/kg administered IV on Day 1 of Cycles 1-6

nivolumab

5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Dung Le, MD

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).

GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

PFS is defined as the number of months from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is \>20% increase in tumor burden compared with nadir, Stable Disease (SD) is \<30% decrease in tumor burden compared with baseline or \<20% increase in tumor burden compared to nadir.

Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Per RECIST 1.1 criteria, PR is defined as =\>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions.

Number of participants with stable or responding (\<50% increase of serum CA19-9 concentration) at 120 days.

Bristol-Myers Squibb

Stand Up To Cancer

Aduro Biotech, Inc.

American Association for Cancer Research

Lustgarten Foundation

CRS-207: 1 × 10\^9 CFU administered IV on Day 2 of Cycles 3-6

GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

nivolumab: 3 mg/kg administered IV on Day 1 of Cycles 1-6

CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Arm A: CY/ GVAX/ CRS-207/ Nivolumab

CRS-207: 1 × 10\^9 CFU administered IV on Day 1 of Cycles 3-6

GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

Arm B: CY/ GVAX/ CRS-207

CY/ GVAX/ CRS-207/ Nivolumab

CRS-207: 1 × 10\^9 CFU administered IV Day 1 of Cycles 3-6

GVAX: 5x10\^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2

CY: 200 mg/m\^2 administered IV on Day 1 of Cycles 1 and 2

CY/ GVAX/ CRS-207

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Overall Survival (OS)

Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity

Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients

Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients

Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients

Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients

Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration

Overall Study

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Ipilimumab

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.

GVAX Pancreas Vaccine

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.

Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.

The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.

Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.

Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.

Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.

Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.

Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.

GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.

CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.

Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207

Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.

Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.

CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.

Arm B: Nivolumab, Ipilimumab, CRS-207

Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207

Age, Categorical

Only 29/30 participants in Arm A were evaluable for this endpoint. One participant was not evaluable after they discontinued prior to their first scan for a reason other than toxicity or progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT	NCT00350181	Leukemia Lymphoma, Non-H... Hematologic Dis... Acute GVHD	Sirolimus MMF BCNU VP-16 CY FTBI BU	2 Years - 60 Years	Stanford University
Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer	NCT06342986	Gynecologic Can... Ovarian Cancer Fallopian Tube ... Primary Periton...	FT536 Fludarabine CY	18 Years -	Masonic Cancer Center, University of Minnesota
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)	NCT01966289	Metastatic Colo...	CY GVAX SGI-110	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab	NCT02243371	Previously Trea...	CRS-207 CRS-207 nivolumab GVAX CY	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)	NCT01966289	Metastatic Colo...	CY GVAX SGI-110	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer	NCT03190265	Pancreatic Canc...	Cyclophosphamid... Nivolumab Ipilimumab GVAX Pancreas V... CRS-207 CRS-207	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT	NCT00350181	Leukemia Lymphoma, Non-H... Hematologic Dis... Acute GVHD	Sirolimus MMF BCNU VP-16 CY FTBI BU	2 Years - 60 Years	Stanford University
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer	NCT03006302	Metastatic Panc...	Epacadostat Pembrolizumab CRS-207 CY GVAX	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer	NCT06342986	Gynecologic Can... Ovarian Cancer Fallopian Tube ... Primary Periton...	FT536 Fludarabine CY	18 Years -	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for cy

Every month we try and update this database with for cy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cy

Every month we try and update this database with for cy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.