Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Interferons

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 1:

1. st vaccine - 0.5 million cells
2. nd vaccine - 1 million cells
3. rd vaccine - 2 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 2:

1. st vaccine - 1 million cells
2. nd vaccine - 2 million cells
3. rd vaccine - 4 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 3:

1. st vaccine - 2 million cells
2. nd vaccine - 4 million cells
3. rd vaccine - 8 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 4:

1. st vaccine - 6 million cells
2. nd vaccine - 6 million cells
3. rd vaccine - 6 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 5:

1. st vaccine - 7 million cells
2. nd vaccine - 7 million cells
3. rd vaccine - 7 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 6:

1. st vaccine - 8 million cells
2. nd vaccine - 8 million cells
3. rd vaccine - 8 million cells

At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.

Autologous DC vaccine

Benjamin Musher, MD

Benjamin Musher

Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor

This is a phase 1, first in man, dose escalation study for safety and feasibility for administration of 3 doses of DC vaccine for pancreatic adenocarcinoma.

The primary objective of this phase 1, first in man trial is to determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with pancreatic adenocarcinoma lysate plus mRNA to pancreatic cancer patients as adjuvant therapy following completion of standard chemotherapy.

Patients will first complete standard treatment for pancreatic adenocarcinoma which is surgically resectable or potentially resectable and then within 3 months of finishing standard treatment, they will have three doses of the dendritic cell vaccine by perinodal injection using ultrasound (US) or computed-tomography (CT) guidance.

This is a single-arm, open-label study where all subjects will receive the DC vaccine. The amount of cells in the vaccine will vary based on the cohort determination and dose escalation schema. Six arms are specified to allow differentiation of the cohorts and their respective dose levels.

Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma

Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)

There is no plan to make IPD available to other researchers.

Maximum tolerated dose of dendritic cell vaccine following completion of surgery and standard adjuvant chemotherapy, as determined by BOIN design. DLTs were defined as shown in the subsequent Primary Outcome Measure.

A DLT is defined as any non-hematologic toxicity of grade 3 or 4 by the Common Terminology Criteria for Adverse Events Version 5.x (CTCAE 5.x) that was probably or definitely DC-vaccine related. Certain grade 4 hematologic toxicities that are probably or definitely DC-vaccine related are also considered DLTs.

Measurement of time from resection surgery to recurrence of pancreatic adenocarcinoma.

Measurement of time from resection surgery to death.

Cancer Cures for Kids

Baylor College of Medicine

Assistant Professor, Medicine - Hematology & Oncology

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

boost radiotherapy (XRT) plus intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate (Autologous DC vaccine) plus High-Dose IL-2

Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccine+IL-2

boost radiotherapy (XRT)

The first dose (7 to 14 x 10_6 total dendritic cells) will be performed with freshly prepared vaccine, 9 days after leukapheresis; on day +1 starting from cycle 2 (3 weeks after the first cycle, on completion of QA assessments on the cryopreserved products), 5 additional doses will be administered every 3 weeks until maximum six vaccines.

high dose IL-2: 18 MIU/m2/day in 500cc administered by continuous IV infusion for 72 hours starting day +2.

High-Dose IL-2

Laura Ridolfi, MD

Single center, open-label Proof of Principle phase II trial to assess objective response (ORR).

Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccine+IL-2. The first day of administration of vaccine is day +1 and of IL-2 is day +2.

Treatment vaccine plus IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72 hours) will be administered every 3 weeks up to 6 cycles.

Total duration of the trial: 36 months

* Enrolment period: 24 months
* Treatment: maximum of 6 cycles (5 months) per patient
* Follow-up every three months until patient died (follow-up until PD and only survival contacts and subsequent therapy for metastatic disease after PD).

Vaccination with dendritic cells pulsed with autologous tumor homogenate in combination with HD-IL2 and immunomodulating radiotherapy in metastatic RCC: a phase II trial Proof of Principle phase II study Study Design Single center, open-label trial to assess response rate Study Duration Total duration: 36 months Enrollment: 24 months Treatment: 5 months per patient Follow-up every three months Primary objectives: Overall Response Rate (ORR) by irRC

Secondary end points:

1. Toxicity
2. Overall Survival
3. Duration of response
4. PFS
5. ORR by RECIST 1.1
6. Prognostic and predictive marker response
7. Immunological response Study Product, Dose, Route, Regimen and duration of administration Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccine+IL-2. The first day of administration of vaccine is day +1 and of IL-2 is day +2.

The intradermal autologous dendritic cell vaccine loaded with autologous tumor homogenate plus IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72 hours) will be administered every 3 weeks up to 6 cycles.

Statistical Methodology

This is a Proof of Principle trial with a minimax two stage design:

• Step 1: 12 patients enrolled; A 5% response rate will preclude further study, whereas a 20% response rate will indicate that further study would be warranted.

Using alfa and beta errors of 0.10, if an objective response is observed in at least 1 of the 12 patients enrolled during the first stage the study will go on with a:

• Step 2: recruitment of an additional 25 patients The treatments will be considered active if an objective response is observed in 4 out of 37 patients treated.

The enrolment period will be 24 months. To ensure patients' safety, a continued safety evaluation by an independent DSMB will be performed and formal rules will be planned to continue or stop the recruitment; in particular, the enrollment will be interrupted when six patients completed at least one cycle of the combo treatment and they will be evaluated for safety: if grade ≥3 AEs (except for fever and rash that will be consider only for grade 4) in 2 (two) or more patients will be observed within 30 days after completion of the first dose of combo treatment, the study will be interrupted.

Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC

Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC: a Phase II Trial (RENALVax-2)

The analysis will be performed on an intention to treat population, i.e. all patients having received at least 2 cycles of therapy.

measured from the date of registration until the date of death from any cause or the last date the patient was known to be alive and will be estimated with Kaplan-Meier method and the log rank test

time calculated from documentation of tumor response to disease progression

measured from registration until disease progression or death

Immunologic efficacy will be measured by best DTH score (reactivity to homogenate or KLH) obtained after at least 4 vaccine doses, alone or combined with IFN-g ELISPOT analysis of tumor antigen-specific circulating effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples

Number of patients with treatment related Adverse events (AE) will be evaluated by CTCAE v 4.03 criteria The percentage of patients reporting an AE up to 30 days after HD-IL-2 treatment will be tabulated with 95% confidence intervals, by type of AE. The overall rate of grade 3-4 related AE will be computed

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Head and Neck Neoplasms

Sarcoma

Neuroendocrine Tumors

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Analgesics

Interleukin-2

Analgesics, Non-Narcotic

7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1), followed by Interleukin (IL) - 2 (IL-2), at a dose of 3 Million Units (MU), given by subcutaneous injection daily for five days (days 3-7). This constitutes a treatment cycle.

Treatment cycles are repeated every 28 days up to a maximum of six cycles.

7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

Autologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).

Oriana Nanni, DR

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS).

This is a single-arm, multi-cohort phase II study, to evaluate the immunological effectiveness and safety of adjuvant Dendritic Cell (DC) vaccination. The evaluation of immunological efficacy will be expressed as the number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease (HNSCC, NET and STS). To avoid unacceptable toxicity, a formal safety analysis will be conducted after six patients have been observed (two for each disease) for at least 30 days after the third treatment cycle. If two or more patients have experienced grade 3 or higher adverse events, enrollment will be definitively stopped; differently, other 15 patients for each disease will be enrolled and evaluation of primary objectives will be done for each cohort separately (H\&N, STS and NET).

A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.

A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head&Neck (H&N), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS).

Incidence, type and severity of adverse events occurred during treatment will be reported and graded according to NCI CTCAE 5.0 criteria

immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT

OS is the time from registration to the time of death from any cause. Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.

RFS is the time from registration to the first date of documented progression (or death for any causes). Subject without progression will be censored at their last tumor assessment date.

Evaluation of the predictive role of a positive DTH test after at least three vaccine administrations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma	NCT04157127	Pancreatic Aden... Pancreatic Canc...	Autologous DC v...	18 Years -	Baylor College of Medicine
Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC	NCT03226236	Carcinoma, Rena... Vaccination Secondary	boost radiother... Autologous DC v... High-Dose IL-2	19 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.	NCT04166006	Head Neck Tumor... Neuroendocrine ... Soft Tissue Sar... Rare Cancer Vaccination	Autologous DC v... Interleukin-2	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Vaccination With Dendritic Cells Pulsed With Autologous Tumor Homogenate in Combination With HD-IL2 and Immunomodulating Radiotherapy in Metastatic RCC	NCT03226236	Carcinoma, Rena... Vaccination Secondary	boost radiother... Autologous DC v... High-Dose IL-2	19 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for autologous dc vaccine