Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Micronutrients

Vasoconstrictor Agents

Docetaxel

Androgens

Calcitriol

Hormones

Calcium

Calcium, Dietary

Vitamins

Trace Elements

DN-101 (calcitriol) - Drug

The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.

This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.

Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

Novacea

Adenocarcinoma

Vaccines

Molgramostim

Sargramostim

Immunomodulating Agents

Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

sipuleucel-T

Robert Israel, MD

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Dendreon

Adverse events were reported in the safety population. The safety population consisted of all subjects who underwent at least 1 infusion.

Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions

Sipuleucel-T

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG 0=Fully Active; No restrictions.

ECOG 1= Restricted Strenuous Activity

ECOG 2=Ambulatory, capable of self-care; no work

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Eastern Cooperative Oncology Group (ECOG) performance status

Gleason Score ≤ 6

Gleason Score = 7

Gleason Score ≥ 8

Gleason Score Missing

Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.

Gleason Score

Shabnam Vaziri

All subjects who received ≥ one sipuleucel-T infusion

Participants who Received At least 1 Infusion

Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004	NCT00285675	Androgen Indepe... Non Small Cell ...	DN-101 (calcitr...	18 Years -	Novacea
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004	NCT00285675	Androgen Indepe... Non Small Cell ...	DN-101 (calcitr...	18 Years -	Novacea
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer	NCT00901342	Prostate Cancer	sipuleucel-T	18 Years -	Dendreon
Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004	NCT00285675	Androgen Indepe... Non Small Cell ...	DN-101 (calcitr...	18 Years -	Novacea

Spots Global Cancer Trial Database for androgen independent prostate cancer (aipc)